-
JBRA Assisted Reproduction Sep 2023Does the use of 400mg pessaries of micronized progesterone provide comparable results as pessaries of 200mg x2, in terms of progesterone levels in hormonal replacement...
OBJECTIVE
Does the use of 400mg pessaries of micronized progesterone provide comparable results as pessaries of 200mg x2, in terms of progesterone levels in hormonal replacement cycles for embryo transfer?.
METHODS
Retrospective cohort study based on 299 embryo transfer treatments under artificial endometrial preparation carried out at Instituto Bernabeu. 131 patients received 1 pessary of 400 mg b.i.d. (group A) and 168 received 2 pessaries of 200 mg b.i.d. (group B).
RESULTS
Mean serum progesterone levels were similar between groups (A: 13.64±4.47ng/mL vs. B: 13.88±7.17ng/mL). There were no differences in suboptimal progesterone levels between groups (A: 11.5% vs. B: 16.8%). In terms of patients receiving additional progesterone supplementation, there were no differences between groups (A: 26% vs. B: 35.3%.). No differences between groups were observed in clinical outcomes: pregnancy rate (PR) (A: 55% vs. B: 54.8%), biochemical pregnancy loss rate (BPLR) (A: 13.4% vs. B: 17.6%), miscarriage rate (MR) (A: 17.9% vs. B: 19.8%) and ongoing pregnancy rate (OPR) (A: 36.5% vs. B: 34.1%).
CONCLUSIONS
One progesterone pessary of 400mg (Cyclogest®) twice daily appears to be non-inferior to the use of two-200mg pessaries twice daily in terms of progesterone levels in HRT cycles.
PubMed: 37768819
DOI: 10.5935/1518-0557.20230021 -
Human Reproduction (Oxford, England) Nov 2023Can supplementation with rectal administration of progesterone secure high ongoing pregnancy rates (OPRs) in patients with low serum progesterone (P4) on the day of...
Rectal progesterone administration secures a high ongoing pregnancy rate in a personalized Hormone Replacement Therapy Frozen Embryo Transfer (HRT-FET) protocol: a prospective interventional study.
STUDY QUESTION
Can supplementation with rectal administration of progesterone secure high ongoing pregnancy rates (OPRs) in patients with low serum progesterone (P4) on the day of blastocyst transfer (ET)?
SUMMARY ANSWER
Rectally administered progesterone commencing on the ET day secures high OPRs in patients with serum P4 levels below 35 nmol/l (11 ng/ml).
WHAT IS KNOWN ALREADY
Low serum P4 levels at peri-implantation in Hormone Replacement Therapy Frozen Embryo Transfer (HRT-FET) cycles impact reproductive outcomes negatively. However, studies have shown that patients with low P4 after a standard vaginal progesterone treatment can obtain live birth rates (LBRs) comparable to patients with optimal P4 levels if they receive additionalsubcutaneous progesterone, starting around the day of blastocyst transfer. In contrast, increasing vaginal progesterone supplementation in low serum P4 patients does not increase LBR. Another route of administration rarely used in ART is the rectal route, despite the fact that progesterone is well absorbed and serum P4 levels reach a maximum level after ∼2 h.
STUDY DESIGN, SIZE, DURATION
This prospective interventional study included a cohort of 488 HRT-FET cycles, in which a total of 374 patients had serum P4 levels ≥35 nmol/l (11 ng/ml) at ET, and 114 patients had serum P4 levels <35 nmol/l (11 ng/ml). The study was conducted from January 2020 to November 2022.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Patients underwent HRT-FET in a public Fertility Clinic, and endometrial preparation included oral oestradiol (6 mg/24 h), followed by vaginal micronized progesterone, 400 mg/12 h. Blastocyst transfer and P4 measurements were performed on the sixth day of progesterone administration. In patients with serum P4 <35 nmol/l (11 ng/ml), 'rescue' was performed by rectal administration of progesterone (400 mg/12 h) starting that same day. In pregnant patients, rectal administration continued until Week 8 of gestation, and oestradiol and vaginal progesterone treatment continued until Week 10 of gestation.
MAIN RESULTS AND THE ROLE OF CHANCE
Among 488 HRT-FET single blastocyst transfers, the mean age of the patients at oocyte retrieval (OR) was 30.9 ± 4.6 years and the mean BMI at ET 25.1 ± 3.5 kg/m2. The mean serum P4 level after vaginal progesterone administration on the day of ET was 48.9 ± 21.0 nmol/l (15.4 ± 6.6 ng/ml), and a total of 23% (114/488) of the patients had a serum P4 level lower than 35 nmol/l (11 ng/ml). The overall, positive hCG rate, clinical pregnancy rate, OPR week 12, and total pregnancy loss rate were 66% (320/488), 54% (265/488), 45% (221/488), and 31% (99/320), respectively. There was no significant difference in either OPR week 12 or total pregnancy loss rate between patients with P4 ≥35 nmol/l (11 ng/ml) and patients with P4 <35 nmol/l, who received rescue in terms of rectally administered progesterone, 45% versus 46%, P = 0.77 and 30% versus 34%, P = 0.53, respectively. OPR did not differ whether patients had initially low P4 and rectal rescue or were above the P4 cut-off. Logistic regression analysis showed that only age at OR and blastocyst scoring correlated with OPR week 12, independently of other factors like BMI and vitrification day of blastocysts (Day 5 or 6).
LIMITATIONS, REASONS FOR CAUTION
In this study, vaginal micronized progesterone pessaries, a solid pessary with progesterone suspended in vegetable hard fat, were used vaginally as well as rectally. It is unknown whether other vaginal progesterone products, such as capsules, gel, or tablet, could be used rectally with the same rescue effect.
WIDER IMPLICATIONS OF THE FINDINGS
A substantial part of HRT-FET patients receiving vaginal progesterone treatment has lowserum P4. Adding rectally administered progesterone in these patients increases the reproductive outcome. Importantly, rectal progesterone administration is considered convenient, and progesterone pessaries are easy to administer rectally and of low cost.
STUDY FUNDING/COMPETING INTEREST(S)
Gedeon Richter Nordic supported the study with an unrestricted grant as well as study medication. B.A. has received unrestricted grant from Gedeon Richter Nordic and Merck and honoraria for lectures from Gedeon Richter, Merck, IBSA and Marckyrl Pharma. P.H. has received honoraria for lectures from Gedeon Richter, Merck, IBSA and U.S.K. has received grant from Gedeon Richter Nordic, IBSA and Merck for studies outside this work and honoraria for teaching from Merck and Thillotts Pharma AB and conference expenses covered by Merck. The other co-authors have no conflict of interest to declare.
TRIAL REGISTRATION NUMBER (25)
EudraCT no.: 2019-001539-29.
Topics: Female; Pregnancy; Humans; Adult; Progesterone; Pregnancy Rate; Prospective Studies; Administration, Rectal; Embryo Transfer; Estradiol; Abortion, Spontaneous; Hormone Replacement Therapy; Retrospective Studies
PubMed: 37759346
DOI: 10.1093/humrep/dead185 -
International Urogynecology Journal Nov 2023This manuscript from Chapter 2 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) reviews the literature involving the clinical... (Review)
Review
International Urogynecology consultation chapter 2 committee 3: the clinical evaluation of pelvic organ prolapse including investigations into associated morbidity/pelvic floor dysfunction.
INTRODUCTION AND HYPOTHESIS
This manuscript from Chapter 2 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) reviews the literature involving the clinical evaluation of a patient with POP and associated bladder and bowel dysfunction.
METHODS
An international group of 11 clinicians performed a search of the literature using pre-specified search MESH terms in PubMed and Embase databases (January 2000 to August 2020). Publications were eliminated if not relevant to the clinical evaluation of patients or did not include clear definitions of POP. The titles and abstracts were reviewed using the Covidence database to determine whether they met the inclusion criteria. The manuscripts were reviewed for suitability using the Specialist Unit for Review Evidence checklists. The data from full-text manuscripts were extracted and then reviewed.
RESULTS
The search strategy found 11,242 abstracts, of which 220 articles were used to inform this narrative review. The main themes of this manuscript were the clinical examination, and the evaluation of comorbid conditions including the urinary tract (LUTS), gastrointestinal tract (GIT), pain, and sexual function. The physical examination of patients with pelvic organ prolapse (POP) should include a reproducible method of describing and quantifying the degree of POP and only the Pelvic Organ Quantification (POP-Q) system or the Simplified Pelvic Organ Prolapse Quantification (S-POP) system have enough reproducibility to be recommended. POP examination should be done with an empty bladder and patients can be supine but should be upright if the prolapse cannot be reproduced. No other parameters of the examination aid in describing and quantifying POP. Post-void residual urine volume >100 ml is commonly used to assess for voiding difficulty. Prolapse reduction can be used to predict the possibility of postoperative persistence of voiding difficulty. There is no benefit of urodynamic testing for assessment of detrusor overactivity as it does not change the management. In women with POP and stress urinary incontinence (SUI), the cough stress test should be performed with a bladder volume of at least 200 ml and with the prolapse reduced either with a speculum or by a pessary. The urodynamic assessment only changes management when SUI and voiding dysfunction co-exist. Demonstration of preoperative occult SUI has a positive predictive value for de novo SUI of 40% but most useful is its absence, which has a negative predictive value of 91%. The routine addition of radiographic or physiological testing of the GIT currently has no additional value for a physical examination. In subjects with GIT symptoms further radiological but not physiological testing appears to aid in diagnosing enteroceles, sigmoidoceles, and intussusception, but there are no data on how this affects outcomes. There were no articles in the search on the evaluation of the co-morbid conditions of pain or sexual dysfunction in women with POP.
CONCLUSIONS
The clinical pelvic examination remains the central tool for evaluation of POP and a system such as the POP-Q or S-POP should be used to describe and quantify. The value of investigation for urinary tract dysfunction was discussed and findings presented. The routine addition of GI radiographic or physiological testing is currently not recommended. There are no data on the role of the routine assessment of pain or sexual function, and this area needs more study. Imaging studies alone cannot replace clinical examination for the assessment of POP.
Topics: Humans; Female; Pelvic Floor; Reproducibility of Results; Pelvic Organ Prolapse; Intussusception; Dysuria; Pain
PubMed: 37737436
DOI: 10.1007/s00192-023-05629-8 -
Family Medicine Apr 2024Improving training and confirming the acquisition of gynecological procedure skills for family physicians (FPs) is crucial for safe health care delivery. The...
BACKGROUND AND OBJECTIVES
Improving training and confirming the acquisition of gynecological procedure skills for family physicians (FPs) is crucial for safe health care delivery. The objectives of this study were to (a) develop performance rating instruments for four gynecological procedures, and (b) pilot them to provide preliminary validity evidence using modern validity theory.
METHODS
Sixteen academic FPs and gynecologists participated in a modified Delphi technique to develop procedure-specific checklists (PSCs) for four procedures: intrauterine device insertion, endometrial biopsy, punch biopsy of the vulva, and routine pessary care. We modified a previously validated global rating scale (GRS) for ambulatory settings. Using prerecorded videos, 19 academic FPs piloted instruments to rate one first-year and one second-year family medicine resident's performance. They were blinded to the level of training. We compared the mean scores for PSCs and GRS for each procedure using paired samples t tests and Cohen's d to estimate effect sizes.
RESULTS
Consensus on items for the final PSCs was reached after two Delphi rounds. PSC and GRS scores were numerically higher for the second-year resident than the first-year resident for every procedure, with statistically significant differences for six of eight comparisons (P<.05). All comparisons demonstrated large effect sizes (Cohen's d>0.8). Both instruments received high scores for ease of use by raters.
CONCLUSIONS
We developed novel performance rating instruments for four gynecological procedures and provided preliminary validity evidence for their use for formative feedback in a simulation setting. This pilot study suggests that these instruments may facilitate the training and documentation of family medicine trainees' skills in gynecological procedures.
Topics: Humans; Pilot Projects; Clinical Competence; Female; Primary Health Care; Internship and Residency; Delphi Technique; Gynecology; Checklist; Family Practice; Educational Measurement
PubMed: 37725774
DOI: 10.22454/FamMed.2023.261011 -
Maturitas Dec 2023Vaginal pessary use is an established, non-surgical treatment option for pelvic organ prolapse. While satisfaction rates are initially high, they seem to decline over...
PURPOSE OF THE RESEARCH
Vaginal pessary use is an established, non-surgical treatment option for pelvic organ prolapse. While satisfaction rates are initially high, they seem to decline over time. We aimed to determine the median duration of pessary use among our patients and to evaluate reasons for discontinuation.
METHODS
All patients who were treated with a vaginal pessary for pelvic organ prolapse between 2007 and 2022 at our institution (a maximum observation period of 15 years) were included in this retrospective cohort study. Data were collected from the in-house electronic databases and the date of pelvic floor surgery was defined as the primary endpoint. In case of no documented surgery, the date of the last follow-up visit (for patients lost to follow-up or who discontinued pessary use without subsequent surgery) or the date of final data collection (for those with presumed continued pessary use) was used as the primary endpoint. Duration of pessary use is represented by Kaplan-Meier curves. Effects of possible confounders were investigated by Cox regression models. A Cox regression model was evaluated for patients with the three most common types of pessary: ring, cube and shell. A chi-square test was performed to compare therapy adherence according to pessary type.
PRINCIPAL RESULTS
Data of 779 patients could be included in the statistical analysis. The estimated median duration of pessary use was 173 weeks (95 % CI 104-473) - approximately 3.3 years. Overall, 30 % of patients opted for surgical therapy and the majority of them did so within 4 months of initiation of pessary use (median time: 19 weeks, 95 % CI 16-26). In 5 % of cases a discontinuation of pessary use without subsequent surgery was documented and 18 % were lost to follow-up before a planned visit, thus leaving 47 % of our patients with presumed continued pessary use. Possible confounding factors for discontinuation of pessary use were tested but were found to be non-significant (body mass index, Pelvic Organ Prolapse - Quantification score, pelvic floor training, age, parity, menopausal status, nicotine consumption, incontinence or size of pessary). Reasons for discontinuation of pessary use were documented in 51 % of patients: unspecified patient wish (23 %), pessary use tiredness (10 %), general dissatisfaction with pessary therapy (7 %), unspecified reasons (5 %), pessary self-change not possible (1 %), erosion, bleeding, pain (2 %); none of the pessary types fitted (2 %).
CONCLUSIONS
According to our data, almost half of our patients with pelvic organ prolapse and pessary therapy continued pessary use until a maximum follow-up time of 15 years, whereas about one-third of patients finally opted for surgical repair (a majority of these within 4 months after pessary therapy initiation). The remaining patients were either lost to follow-up or discontinued pessary use without subsequent surgery. The stated reasons for discontinuation of pessary use were mostly non-specific, but only 1 % reported that pessary self-change was not possible. Erosion bleeding or pain was documented in only 2 % of cases as reason for discontinuation. This information helps clinicians to inform their patients with pelvic organ prolapse about expected pessary therapy success and strengthens individual counselling. Furthermore, our data indicates vaginal pessary use for pelvic organ prolapse is feasible and safe for all women and that therapy adherence can extend beyond 5 years.
Topics: Humans; Female; Pessaries; Retrospective Studies; Pelvic Organ Prolapse; Surveys and Questionnaires; Pain
PubMed: 37659128
DOI: 10.1016/j.maturitas.2023.107828 -
Journal of Obstetrics and Gynaecology... Dec 2023Treatment options for cases of pelvic organ prolapse still lead to the use of a pessary rather than a surgical method. Additional therapy is needed to help treat or... (Review)
Review
OBJECTIVES
Treatment options for cases of pelvic organ prolapse still lead to the use of a pessary rather than a surgical method. Additional therapy is needed to help treat or prevent pelvic organ prolapse. Vitamin D deficiency has consistently been associated with decreased muscle function, so it is assumed that it will affect the pelvic floor muscles. This paper systematically explores the differences between 25-hydroxyvitamin D levels in patients with pelvic organ prolapse and non-pelvic organ prolapse.
STUDY DESIGN
A systematic review was conducted through the PubMed, Google Scholar, Cochrane Library, and ScienceDirect databases using relevant keywords. Articles published in the last 10 years-from 2012 to 2022-that were written in English, that discuss the status or effect of vitamin D on pelvic organ prolapse, and that focus on 25 OH-vitamin D were included in the review.
RESULTS
In total, 717 articles were filtered but 8 articles met the criteria. A total of 1339 women with prolapse and without prolapse with ages ranging from 20 years to 78 years were included in the study. The studies found did not use the same standard threshold in determining deficiency status. Most studies have found that there are lower levels of vitamin D in women who have had pelvic organ prolapse. A total of 7 of 8 studies confirmed the comparison of vitamin D-25OH levels in women with pelvic organ prolapse and without pelvic organ prolapse at P < 0.05.
CONCLUSIONS
There are differences between 25-hydroxyvitamin D levels in patients with pelvic organ prolapse and non-pelvic organ prolapse.
Topics: Humans; Female; Pelvic Floor; Pelvic Organ Prolapse; Vitamin D; Calcifediol; Vitamins; Pessaries
PubMed: 37633644
DOI: 10.1016/j.jogc.2023.102198 -
Menopause (New York, N.Y.) Sep 2023This study aimed to apply three-dimensional (3D) printing technology to treat women with pelvic organ prolapse (POP) and to evaluate efficacy based on the improvement by...
OBJECTIVE
This study aimed to apply three-dimensional (3D) printing technology to treat women with pelvic organ prolapse (POP) and to evaluate efficacy based on the improvement by quality of life (QOL) questionnaires.
METHODS
This was a pilot study at a tertiary urogynecology unit in Taiwan. Between January 2021 and June 6, 2021, participants who opted for self-management using Gellhorn pessaries to treat symptomatic POP were enrolled. For each woman, the original Gellhorn pessary was placed into the vagina to restore the prolapsed tissues and under transvaginal ultrasound guided to evaluate the gap which the Gellhorn pessary cannot cover. Otoform (an impression silicone) was used to make a model and have it hooked onto Gellhorn pessary (template). We collected templates and then applied 3D printing to customize the silicone vaginal pessary. All women completed multiple validated QOL questionnaires at baseline and at 3 and 6 months.
RESULTS
Six women completed the study. The QOL questionnaires revealed significant improvements across the board.
CONCLUSIONS
Our study demonstrates that a tailor made 3D pessary can be used for women with POP. A customized pessary can be made with the help of transvaginal ultrasound and 3D printing technology.
Topics: Female; Humans; Pessaries; Pilot Projects; Quality of Life; Pelvic Organ Prolapse; Printing, Three-Dimensional; Silicones
PubMed: 37625089
DOI: 10.1097/GME.0000000000002223 -
Cureus Jul 2023Aims and Objectives To compare the safety and efficacy of dinoprostone pessary with Foley plus vaginal misoprostol for cervical ripening. Materials and Methods We...
Aims and Objectives To compare the safety and efficacy of dinoprostone pessary with Foley plus vaginal misoprostol for cervical ripening. Materials and Methods We randomized 115 women to the pessary or Foley plus misoprostol group. Pessary was inserted for 24 hours, and in the Foley plus misoprostol group, intravaginal misoprostol 25 mcg was administered along with trans-cervical Foley insertion and repeated every six hours to a maximum dose of 100 mcg. Singleton pregnancies requiring labor induction at more than 34 weeks with a Bishop score of <6 were included. Study outcomes included induction-delivery interval (IDI), mode of delivery, change in the Bishop score, need for oxytocin augmentation, and patient discomfort as assessed by visual analog score. Results The IDI was similar between the groups (pessary vs Foley plus misoprostol; 21.27 vs 21.10 hours, p = 0.9). The mean change in the Bishop score and need for augmentation with oxytocin was significantly more in the Foley plus misoprostol group compared to pessary (2.72 vs 1.94, p = 0.001; 89.7% vs 57.9%, p = 0.0001). Pessary was better tolerated compared to Foley plus misoprostol (VAS 7.8 vs 6.68, p = 0.0001). Mode of delivery and maternal and neonatal outcomes showed no difference. Conclusion There was no significant difference between pessary and Foley plus misoprostol in the IDI and mode of delivery. Pessary was better tolerated, and augmentation with oxytocin was required less often. Foley plus misoprostol caused a faster change in the Bishop score, but oxytocin augmentation was used more often. Maternal and neonatal outcomes were similar.
PubMed: 37605669
DOI: 10.7759/cureus.42261 -
JAMA Aug 2023In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse.... (Comparative Study)
Comparative Study Randomized Controlled Trial
IMPORTANCE
In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure.
OBJECTIVE
To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent.
DESIGN, SETTING, AND PARTICIPANTS
Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen.
INTERVENTIONS
Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217).
MAIN OUTCOMES AND MEASURES
The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications.
RESULTS
Among 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of -9% for the lower limit of the CI (risk difference, -10.3%; 95% CI, -17.8% to -2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups.
CONCLUSIONS
Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure.
TRIAL REGISTRATION
TrialRegister.nl Identifier: NTR 6978.
Topics: Female; Humans; Middle Aged; Gynecologic Surgical Procedures; Pelvic Organ Prolapse; Treatment Outcome; Uterine Prolapse; Uterus; Aged
PubMed: 37581670
DOI: 10.1001/jama.2023.13140 -
Annals of Medicine and Surgery (2012) Aug 2023Uterine prolapse (UP) is rare during pregnancy. It sometimes leads to serious complications such as abortion, preterm labor, and maternal death. The main risk factor for...
UNLABELLED
Uterine prolapse (UP) is rare during pregnancy. It sometimes leads to serious complications such as abortion, preterm labor, and maternal death. The main risk factor for UP is previous vaginal childbirth and is usually managed conservatively. However, surgery should be considered in cases of unavailability or failure of conservative approaches.
CASE PRESENTATION
A 34-year-old Gravid4Para3 pregnant woman in the 33rd week of gestation presented with refractory vaginal pain. She had a remarkable history of second-degree UP. Upon presentation, the anterior and posterior cervical lips were swollen, bluish, and protruding through the vagina. Considering the severe pain, the alarming examination findings, and the impossibility of pushing back the protruding mass, a total vaginal hysterectomy was performed. The postoperative pathological study revealed a massive hemorrhage with edematous changes in the vaginal cuff and cervical mucosa in addition to features of placenta accreta, placenta previa, and placenta abruption.
CONCLUSIONS
UP is a rare but potentially serious condition, especially if it is related to pregnancy. Moreover, managing UP could be challenging in low-income settings, where even simple conservative methods might be unavailable or financially unattainable.
PubMed: 37554873
DOI: 10.1097/MS9.0000000000001044