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Fertility and Sterility Feb 2024
Response to: Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection.
Topics: Humans; Male; Fertilization in Vitro; Follicle Stimulating Hormone; Menotropins; Ovulation Induction; Recombinant Proteins; Semen; Sperm Injections, Intracytoplasmic; Randomized Controlled Trials as Topic
PubMed: 37734649
DOI: 10.1016/j.fertnstert.2023.09.008 -
Journal of Clinical Pharmacology Dec 2023The purpose of this research was to evaluate the efficacy of 3 ovulation induction therapies for treating infertility in patients with polycystic ovary syndrome (PCOS).... (Randomized Controlled Trial)
Randomized Controlled Trial
The purpose of this research was to evaluate the efficacy of 3 ovulation induction therapies for treating infertility in patients with polycystic ovary syndrome (PCOS). In this retrospective study, we compared the success rates of 90 patients who underwent intrauterine insemination, who were randomly assigned to 1 of 3 treatment groups: letrozole (LE) + urinary gonadotropin (human menopausal gonadotropin [HMG]), clomiphene (CC) + HMG, or HMG alone. Using ultrasound scanning, we examined the number of mature follicles, ovulation rate, clinical pregnancy rate, endometrial thickness, and blood flow. When compared to the other 2 groups, the LE + HMG group had significantly higher levels of mature follicles, ovulation rate, clinical pregnancy rate, estradiol, and luteinizing hormone on the day of the human chorionic gonadotropin injection and endometrial receptivity (P < .05). There was no statistically significant difference between the 3 groups in terms of abortion rate, ectopic pregnancy rate, or adverse reactions. In this research, we found that infertility in patients with PCOS could be effectively treated by combining LE with HMG. This protocol increased ovulation, boosted fertility, and enhanced endometrial receptivity with no increase in adverse reactions. Therefore, it may be a useful clinical approach for inducing ovulation and treating infertility in patients with PCOS.
Topics: Pregnancy; Female; Humans; Polycystic Ovary Syndrome; Infertility, Female; Fertility Agents, Female; Retrospective Studies; Letrozole; Ovulation Induction; Menotropins
PubMed: 37493193
DOI: 10.1002/jcph.2318 -
BMC Pregnancy and Childbirth Jul 2023GnRHa and hCG are both used for oocyte maturation and ovulation triggering. However, GnRHa have a shorter half-life than hCG, which leads to luteal phase deficiency....
BACKGROUND
GnRHa and hCG are both used for oocyte maturation and ovulation triggering. However, GnRHa have a shorter half-life than hCG, which leads to luteal phase deficiency. Letrozole (LE) has been found to improve the luteal function. Thus, the choice of triggering strategy can be different in intrauterine insemination (IUI) cycles using LE and human menopausal gonadotropin (HMG). The aim of this study was to compare the pregnancy and neonatal outcomes of patients triggered with GnRHa versus hCG versus dual trigger in LE-IUI cycles.
METHODS
This retrospective cohort study included 6,075 LE-HMG IUI cycles between January 2010 and May 2021 at a tertiary-care academic medical center in China. All cycles were divided into three groups according to different trigger strategies as hCG trigger group, GnRHa trigger group and dual trigger group. The primary outcome was clinical pregnancy rate. Logistic regression analysis was performed to explore other risk factors for clinical pregnancy rate.
RESULTS
No significant difference was observed in clinical pregnancy rate between hCG, GnRHa and dual trigger cycles in LE-HMG IUI cycles (P = 0.964). The miscarriage rate was significantly lower in the GnRHa trigger group, and higher in the dual trigger group, compared with the hCG group (P = 0.045). Logistic analysis confirmed that triggering strategy was associated with miscarriage (aOR:0.427, 95%CI: 0.183-0.996, P = 0.049; aOR:0.298, 95%CI: 0.128-0.693, P = 0.005). No significant differences were observed regarding neonatal outcomes between the three groups.
CONCLUSIONS
Our findings suggested that both GnRHa and dual trigger can be used to trigger ovulation in LE-HMG IUI cycles, but dual trigger must be used with caution.
Topics: Pregnancy; Female; Infant, Newborn; Humans; Letrozole; Menotropins; Abortion, Spontaneous; Retrospective Studies; Ovulation Induction; Chorionic Gonadotropin; Fertilization in Vitro; Pregnancy Rate; Insemination, Artificial; Gonadotropin-Releasing Hormone
PubMed: 37442967
DOI: 10.1186/s12884-023-05835-8 -
Gynecologic and Obstetric Investigation 2023The aim of the study was to evaluate dosing of recombinant human luteinizing hormone (r-hLH) or human menopausal gonadotrophin (hMG)-derived medications with LH activity...
Dosing Characteristics of Recombinant Human Luteinizing Hormone or Human Menopausal Gonadotrophin-Derived LH Activity in Patients Undergoing Ovarian Stimulation: A German Fertility Database Study.
OBJECTIVES
The aim of the study was to evaluate dosing of recombinant human luteinizing hormone (r-hLH) or human menopausal gonadotrophin (hMG)-derived medications with LH activity in ovarian stimulation (OS) cycles for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI).
DESIGN
A non-interventional study was performed to analyse data from the German RecDate database (January 2007-December 2011).
PARTICIPANTS/MATERIALS, SETTING, METHODS
Starting/total r-hLH/hMG dose, OS duration/cycle number, r-hLH/hMG initiation day (first day of administration), and population/cycle characteristics were assessed in women (≥18 years) undergoing OS for IVF/ICSI using r-hLH or hMG-derived medications (excluding corifollitropin alfa, clomiphene citrate, letrozole, mini/micro-dose human chorionic gonadotrophin, and urofollitropin alone). Data were summarized descriptively.
RESULTS
67,858 identified cycles utilized medications containing r-hLH (10,749), hMG (56,432), or both (677). Mean (standard deviation) OS duration with r-hLH and hMG was 10.1 (4.43) and 9.8 (6.16) days, respectively. Median (25th-75th percentile) r-hLH starting dose (75.0 [75.0-150.0] IU) was consistent across patients regardless of age, infertility diagnosis, or gonadotrophin-releasing hormone (GnRH) protocol. Median (25th-75th percentile) hMG-derived LH activity starting dose was 225.0 (150.0-300.0) IU, regardless of GnRH protocol, but was lower in women aged <35 years and those with ovulation disorders/polycystic ovary syndrome. Median (25th-75th percentile) total dose for r-hLH (750.0 [337.5-1,125.0] IU) and hMG-derived LH activity (1,575.0 [750.0-2,625.0] IU) varied according to patients' age, infertility diagnosis, cycle number, and r-hLH/hMG initiation day. GnRH antagonist use resulted in a numerically higher median total hMG-derived LH activity dose than GnRH agonist use.
LIMITATIONS
The data used in this study were taken from electronic medical records relating to a specific timeframe (2007-2011) and therefore may not accurately reflect current clinical practice; however, it is likely that the differences between the two compounds would be maintained. Additionally, secondary data sources may suffer from uniformity and quality issues.
CONCLUSIONS
The standard of care for OS cycles is described with respect to IVF/ICSI treatment including an LH component in Germany during the specified timeframe.
Topics: Humans; Female; Male; Semen; Luteinizing Hormone; Menotropins; Ovulation Induction; Gonadotropin-Releasing Hormone; Fertilization in Vitro; Infertility; Menopause; Fertility
PubMed: 37369184
DOI: 10.1159/000530360 -
Reproduction in Domestic Animals =... Jun 2023Human menopausal gonadotrophin (hMG) has been reported to produce a comparable superovulatory response to that of follicle stimulating hormone (FSH). Furthermore, hMG...
Human menopausal gonadotrophin (hMG) has been reported to produce a comparable superovulatory response to that of follicle stimulating hormone (FSH). Furthermore, hMG has a long half-life as compared with FSH. The present study was designed to compare hMG administered once daily and FSH administered twice daily over a 4 - day period on superovulatory response of Suffolk ewes. During the mid-luteal phase, twenty-four Suffolk donor ewes received intravaginal sponges at day 0 for 12 days. The superovulatory regimens in the Control group (n = 12) and the Treatment group (n = 12) consisted of eight injections of FSH given at twice daily and four injections of hMG given at once daily, respectively. At day 13, the donor ewes were subjected to laparoscopic insemination. Embryos were recovered, classified, and transferred to recipient ewes at day 19. Pregnancy status was determined by ultrasound examination 40 days after transfer. Lambing rate was calculated after all the ewes had delivered. No significant differences were observed between the two groups in terms of the structures recovered, transferable embryos, degenerated embryos, unfertilized oocytes, pregnancy rate and lambing rate. The results showed that once daily injection of hMG can produce a comparable superovulatory response and embryo transfer outcomes to those obtained by twice daily injection of FSH over a 4 - day period. It is feasible that hMG is used to replace FSH and reduce the number of injection treatments in ovine superovulatory regimens.
Topics: Pregnancy; Sheep; Animals; Female; Humans; Menotropins; Seasons; Follicle Stimulating Hormone; Superovulation; Sheep, Domestic; Breeding; Follicle Stimulating Hormone, Human
PubMed: 36929184
DOI: 10.1111/rda.14342 -
Medical Care Apr 2023Health care claims have an inherent limitation in that noncovered services are unreported. This limitation is particularly problematic when researchers wish to study the...
BACKGROUND
Health care claims have an inherent limitation in that noncovered services are unreported. This limitation is particularly problematic when researchers wish to study the effects of changes in the insurance coverage of a service. In prior work, we studied the change in the use of in vitro fertilization (IVF) after an employer added coverage. To estimate IVF use before coverage began, we developed and tested an Adjunct Services Approach that identified patterns of covered services cooccurring with IVF.
METHODS
Based on clinical expertise and guidelines, we developed a list of candidate adjunct services and used claims data after IVF coverage began to assess associations of those codes with known IVF cycles and whether any additional codes were also strongly associated with IVF. The algorithm was validated by primary chart review and was then used to infer IVF in the precoverage period.
RESULTS
The selected algorithm included pelvic ultrasounds and either menotropin or ganirelix, yielding a sensitivity of 93.0% and specificity of >99.9%.
DISCUSSION
The Adjunct Services Approach effectively assessed the change in IVF use postinsurance coverage. Our approach can be adapted to study IVF in other settings or to study other medical services experiencing coverage changes (eg, fertility preservation, bariatric surgery, and sex confirmation surgery). Overall, we find that an Adjunct Services Approach can be useful when (1) clinical pathways exist to define services delivered adjunct to the noncovered service, (2) those pathways are followed for most patients receiving the service, and (3) similar patterns of adjunct services occur infrequently with other procedures.
Topics: Humans; Insurance, Health; Fertilization in Vitro
PubMed: 36893407
DOI: 10.1097/MLR.0000000000001823 -
Best Practice & Research. Clinical... Jun 2023This comparative non-interventional study using data from the French National Health Database (Système National des Données de Santé) investigated real-world... (Comparative Study)
Comparative Study Observational Study
Comparative effectiveness of gonadotropins used for ovarian stimulation during assisted reproductive technologies (ART) in France: A real-world observational study from the French nationwide claims database (SNDS).
This comparative non-interventional study using data from the French National Health Database (Système National des Données de Santé) investigated real-world (cumulative) live birth outcomes following ovarian stimulation, leading to oocyte pickup with either originator recombinant human follicle-stimulating hormone (r-hFSH) products (alfa or beta), r-hFSH alfa biosimilars, or urinaries including mainly HP-hMG (menotropins), and marginally u-hFSH-HP (urofollitropin). Using data from 245,534 stimulations (153,600 women), biosimilars resulted in a 19% lower live birth (adjusted odds ratio (OR) 0.81, 95% confidence interval (CI) 0.76-0.86) and a 14% lower cumulative live birth (adjusted hazard ratio (HR) 0.86, 95% CI 0.82-0.89); and urinaries resulted in a 7% lower live birth (adjusted OR 0.93, 95% CI 0.90-0.96) and an 11% lower cumulative live birth (adjusted HR 0.89, 95% CI 0.87-0.91) versus originator r-hFSH alfa. Results were consistent across strata (age and ART strategy), sensitivity analysis using propensity score matching, and with r-hFSH alfa and beta as the reference group.
Topics: Female; Humans; Pregnancy; Biosimilar Pharmaceuticals; Follicle Stimulating Hormone, Human; Gonadotropins; Ovulation Induction; Reproductive Techniques, Assisted
PubMed: 36707343
DOI: 10.1016/j.bpobgyn.2022.102308 -
Frontiers in Endocrinology 2022To compare the effects of human menopausal gonadotropin (HMG) combined with letrozole (LE) to HMG only for ovarian stimulation on pregnancy outcome of infertile patients...
Retrospective analysis: The application of human menopausal gonadotropin combined with letrozole for IUI in patients undergoing artificial insemination by husband due to unexplained or mild male factors.
OBJECTIVE
To compare the effects of human menopausal gonadotropin (HMG) combined with letrozole (LE) to HMG only for ovarian stimulation on pregnancy outcome of infertile patients undergoing artificial insemination by husband (AIH) due to unexplained or mild male factors.
MATERIALS AND METHODS
Infertile patients with unexplained or mild male factors treated from July 2015 to December 2021 were selected as subjects. The patients were divided into two groups according to the ovarian stimulation schemes they received, namely HMG combined with LE or HMG only. We analyzed the laboratory examination results before drug treatment (baseline) and during ovarian stimulation and compared the pregnancy outcomes of the two groups using univariable analysis and multivariable logistic regression analysis.
RESULTS
In total, 526 cycles of 372 couples were included. The univariate analysis showed that the clinical pregnancy rate of the HMG combined with LE group was 24.8%, significantly higher than that of the HMG group (14.8%, P = 0.007). The live birth rate (19.9%) of the HMG combined with LE group were also significantly higher than those of the HMG group (11.2%, respectively). In multivariate logistic analysis, the age of males was negatively associated with the clinical pregnancy rate (OR 0.874, 95% CI 0.793~0.963, P=0.006) and live birth (OR0.875, 95% CI 0.783~0.977, P=0.018). Moreover, ovarian stimulation with HMG+LE was the only beneficial factor significantly associated with clinical pregnancy (OR 1.929, 95% CI 1.068~3.485, P=0.029) and live birth (OR 2.255, 95% CI 1.188~4.282, P=0.013).
CONCLUSION
Ovarian stimulation using HMG combined with LE can increase the clinical outcomes (live birth and clinical pregnancy) among infertile patients undergoing AIH due to explained or mild male factors.
Topics: Female; Humans; Pregnancy; Male; Letrozole; Menotropins; Retrospective Studies; Spouses; Insemination, Artificial; Infertility
PubMed: 36605946
DOI: 10.3389/fendo.2022.1038433 -
Reproductive Biomedicine Online Mar 2023Does follicular stimulation using human menopausal gonadotrophin (HMG) after pituitary down-regulation by a GnRH agonist improve endometrial thickness (EMT) and clinical...
RESEARCH QUESTION
Does follicular stimulation using human menopausal gonadotrophin (HMG) after pituitary down-regulation by a GnRH agonist improve endometrial thickness (EMT) and clinical outcomes of frozen-thawed embryo transfer (FET; using vitrified-warmed embryos) in women with thin endometrium after intensified oestrogen administration (IOA)?
DESIGN
This was a retrospective study. A total of 627 patients attempted 683 FET cycles with at least one previous history of thin endometrium. None of the cycles reached over 7 mm EMT after using oral and vaginal oestradiol for more than 21 days (IOA protocol). A total of 129 cycles proceeded with FET, 305 cycles were cancelled, and 249 cycles involved administration of HMG following GnRH agonist pituitary down-regulation (GnRH agonist + HMG protocol) for further endometrial preparation.
RESULTS
EMT became significantly greater (7.18 ± 1.14 mm versus 6.13 ± 0.63 mm, P < 0.001) using GnRH agonist + HMG compared with previous IOA cycles, but this was not related to serum oestrogen concentrations. A total of 213 cycles after the GnRH agonist + HMG protocol proceeded with FET, showing a significantly increased clinical pregnancy rate, implantation rate and live birth rate compared with those after IOA.
CONCLUSIONS
The GnRH agonist + HMG protocol for endometrial preparation in FET cycles improves EMT in women with a thin endometrium after IOA and showed significantly better clinical outcomes than IOA. The authors suggest that the GnRH agonist + HMG protocol should be used for EMT that is less than 7 mm after there has been no optimal response to IOA.
Topics: Pregnancy; Humans; Female; Retrospective Studies; Cryopreservation; Embryo Transfer; Pregnancy Rate; Estrogens; Menotropins; Gonadotropin-Releasing Hormone; Endometrium; Ovulation Induction
PubMed: 36604214
DOI: 10.1016/j.rbmo.2022.12.003 -
Journal of Assisted Reproduction and... Jan 2023An impact of different gonadotrophins selection for ovarian stimulation (OS) on oocyte competence has yet to be defined. In this study, we asked whether an association...
PURPOSE
An impact of different gonadotrophins selection for ovarian stimulation (OS) on oocyte competence has yet to be defined. In this study, we asked whether an association exists between OS protocol and euploid blastocyst rate (EBR) per metaphase-II (MII) oocytes.
METHODS
Cycles of first preimplantation genetic testing for aneuploidies conducted by women ≥ 35 years old with their own metaphase-II oocytes inseminated in the absence of severe male factor (years 2014-2018) were clustered based on whether recombinant FSH (rec-FSH) or human menopausal gonadotrophin (HMG) was used for OS, then matched for the number of fresh inseminated eggs. Four groups were outlined: rec-FSH (N = 57), rec-FSH plus rec-LH (N = 55), rec-FSH plus HMG (N = 112), and HMG-only (N = 127). Intracytoplasmic sperm injection, continuous blastocyst culture, comprehensive chromosome testing to assess full-chromosome non-mosaic aneuploidies and vitrified-warmed euploid single embryo transfers (SETs) were performed. The primary outcome was the EBR per cohort of MII oocytes. The secondary outcome was the live birth rate (LBR) per first SETs.
RESULTS
Rec-FSH protocol was shorter and characterized by lower total gonadotrophin (Gn) dose. The linear regression model adjusted for maternal age showed no association between the Gn adopted for OS and EBR per cohort of MII oocytes. Similarly, no association was reported with the LBR per first SETs, even when adjusting for blastocyst quality and day of full blastulation.
CONCLUSION
In view of enhanced personalization in OS, clinicians shall focus on different endpoints or quantitative effects related to Gn action towards follicle recruitment, development, and atresia. Here, LH and/or hCG was administered exclusively to women with expected sub/poor response; therefore, we cannot exclude that specific Gn formulations may impact patient prognosis in other populations.
Topics: Male; Female; Humans; Adult; Case-Control Studies; Maternal Age; Metaphase; Semen; Gonadotropins; Oocytes; Ovulation Induction; Menotropins; Follicle Stimulating Hormone; Aneuploidy; Fertilization in Vitro
PubMed: 36586005
DOI: 10.1007/s10815-022-02684-w