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Fertility and Sterility Jan 1991From the reviewed data, it appears that CC, hMG-hCG, or the association of these drugs with IVF-ET and GIFT programs do not carry an increased risk for congenital... (Review)
Review
Early miscarriage and fetal malformations after induction of ovulation (by clomiphene citrate and/or human menotropins), in vitro fertilization, and gamete intrafallopian transfer.
From the reviewed data, it appears that CC, hMG-hCG, or the association of these drugs with IVF-ET and GIFT programs do not carry an increased risk for congenital malformations as a whole, nor is there any specific malformation that has an increased incidence or is related in any way with the use of these drugs. Table 7 represents the specific malformation rate per 1,000 births in the general population and in newborns delivered after treatment with CC, hMG-hCG, or IVF-ET and GIFT. The malformation rate in the treated groups does not differ from that of the general population. However, as shown by McIntosh et al., the incidence of congenital malformations often rises with a longer follow-up. Most of the reports about babies born after ovulation induction are based on the initial examination done shortly after birth. Thus, studies including examination of these infants up to at least 12 months of age will be undoubtedly of value. Also, data concerning the reproductive capability of women born after ovulation induction is lacking. With regard to the abortion rate in pregnancies achieved after such treatments and procedures, it can be concluded that it does not appear to be higher than that of the general population, particularly when early pregnancy loss, advanced maternal age, the infertility status, and the increased incidence of multiple pregnancies occurring in these patients are taken into consideration.
Topics: Abortion, Spontaneous; Clomiphene; Congenital Abnormalities; Female; Fertilization in Vitro; Gamete Intrafallopian Transfer; Humans; Menotropins; Ovulation Induction; Pregnancy
PubMed: 1898885
DOI: 10.1016/s0015-0282(16)54048-5 -
Fertility and Sterility Sep 1992Whereas the dose of hMG is significantly correlated with both BMI and BW, commencing the more obese patient on higher hMG doses is not justified in view of the...
Whereas the dose of hMG is significantly correlated with both BMI and BW, commencing the more obese patient on higher hMG doses is not justified in view of the cancellation of cycles from over-responsiveness in the more obese patients started on higher hMG dosage regimens. If the more obese patient is slow to respond, however, a greater degree of clinical freedom may be exercised to increase the dose. The ultimate outcome of the cycle is not related to BMI, BW, or the dose of hMG used.
Topics: Aging; Body Mass Index; Body Weight; Female; Humans; Menotropins; Ovulation Induction; Polycystic Ovary Syndrome; Pregnancy
PubMed: 1521660
DOI: 10.1016/s0015-0282(16)55276-5 -
Reproductive Biology and Endocrinology... Sep 2010Human menopausal gonadotrophins and recombinant human follicle stimulating hormone are the two main gonadotrophin products utilized for controlled ovarian stimulation in... (Comparative Study)
Comparative Study Meta-Analysis Review
Recombinant human follicle-stimulating hormone produces more oocytes with a lower total dose per cycle in assisted reproductive technologies compared with highly purified human menopausal gonadotrophin: a meta-analysis.
BACKGROUND
Human menopausal gonadotrophins and recombinant human follicle stimulating hormone are the two main gonadotrophin products utilized for controlled ovarian stimulation in assisted reproductive technologies. In this meta-analysis, the number of oocytes was designated as the most relevant endpoint directly resulting from ovarian stimulation, and therefore where the drug effect may be estimated with the best sensitivity.
METHODS
All published randomized controlled trials on ovarian stimulation comparing the two gonadotrophin products were evaluated. Internal validity was determined using Chalmers' validated scale. If trials did not meet the established quality criteria, a sensitivity analysis assessed the stability of the results. The comparison of continuous variables was conducted following the weighted mean difference and the standardized mean difference (Cohen's effect size) with the random model. Given the known relationship of baseline conditions on treatment endpoints, results were adjusted for age, body mass index and type of infertility.
RESULTS
Sixteen studies involving 4040 patients were included. Treatment with human menopausal gonadotrophins resulted in fewer oocytes (-1.54; 95% CI: -2.53 to -0.56; P < 0.0001) compared to recombinant human follicle-stimulating hormone. When adjusting for baseline conditions, the mean difference estimate was -2.10 (95% CI: -2.83 to -1.36; P < 0.001). A higher total dose of human menopausal gonadotrophin was necessary (mean difference, 235.46 IU [95% CI: 16.62 to 454.30; P = 0.03]; standardized mean difference, 0.33 [95% CI: 0.08 to 0.58; P = 0.01]). The pregnancy absolute risk difference (RD [hMG-r-hFSH]) for fresh transfers was 3% (P = 0.051), and the relative risk 1.10 (P = 0.06). When adjusted for baseline conditions, the relative risk was 1.04 (P = 0.49) and absolute difference was 0.01 (P = 0.34), respectively.
CONCLUSIONS
Because baseline conditions are predictive of outcome, meta-analytic results are more sensitive when these variables are considered. Using an endpoint closely associated with the stimulation period, sufficient sensitivity is achieved to compare gonadotrophin treatments. As the largest meta-analysis published to date on this subject, treatment with human menopausal gonadotrophins is characterized by fewer oocytes and a higher total dose. When considering only fresh transfers, pregnancy rates were similar.
Topics: Cell Count; Dose-Response Relationship, Drug; Female; Fertility Agents, Female; Follicle Stimulating Hormone, Human; Humans; Infertility; Menotropins; Menstrual Cycle; Oocytes; Ovulation Induction; Pregnancy; Recombinant Proteins; Reproductive Techniques, Assisted; Treatment Outcome
PubMed: 20846363
DOI: 10.1186/1477-7827-8-112 -
Fertility and Sterility Jun 1996To examine the difference in efficacy between two protocols of superovulation induction with IUI among infertile couples. (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
OBJECTIVE
To examine the difference in efficacy between two protocols of superovulation induction with IUI among infertile couples.
DESIGN
A prospective randomized trial.
SETTING
Normal human volunteers in an infertility clinic.
PATIENTS
Consecutively treated patients attending our infertility clinic for superovulation induction with IUI who had been unsuccessfully treated by clomiphene citrate (CC).
INTERVENTIONS
Infertile couples were randomized to undergo one of two controlled ovarian hyperstimulation protocols. Group A patients received daily hMG beginning on cycle day 3, whereas group B patients were administered CC days 3 through 7, followed by hMG from day 7 onward. Randomization was performed using a random numbers table. In both groups, ovulation was triggered by 5,000 IU hCG and IUI was performed by 36 hours.
MAIN OUTCOME MEASURES
Studied cycle performance parameters included peak E2, number of dominant and intermediate-sized follicles recruited, endometrial thickness and pattern, and frequency of monitoring.
RESULTS
Data analysis demonstrated no significant difference between the two groups with respect to patient age, parity, weight, indication for superovulation and IUI, number of dominant follicles recruited, peak E2, or mean number of total motile sperm inseminated. Endometrial thickness and pattern differed between treatments, however, with group A demonstrating relatively thicker and proportionately more trilaminar patterns than group B. Group A had significantly more serum E2 measurements, as well as transvaginal sonograms performed, when compared with group B. Pregnancy rates for groups A and B were 0.192 and 0.091, respectively. Of 25 pregnancies in group A, 7 (0.28) were multiples, whereas there were no multiple gestations in group B.
CONCLUSION
For patients undergoing superovulation with IUI, a menotropin-alone protocol yields significantly higher pregnancy rates than one using a combination of menotropin with CC. These differences could not be explained by patient characteristics. Among cycle performance parameters, endometrial thickness and pattern differed significantly between the two groups.
Topics: Adult; Clomiphene; Estradiol; Female; Humans; Infertility; Male; Menotropins; Ovulation Induction; Pregnancy; Pregnancy Outcome; Prospective Studies; Superovulation
PubMed: 8641492
DOI: 10.1016/s0015-0282(16)58333-2 -
Clinical Drug Investigation Dec 2016Highly purified human menotrophin and urofollitrophin preparations obtained from human urine via a novel patented purification method have been tested over a timeframe... (Randomized Controlled Trial)
Randomized Controlled Trial
Pharmacokinetics and Pharmacodynamics of Follicle-Stimulating Hormone in Healthy Women Receiving Single and Multiple Doses of Highly Purified Human Menotrophin and Urofollitrophin.
BACKGROUND AND OBJECTIVE
Highly purified human menotrophin and urofollitrophin preparations obtained from human urine via a novel patented purification method have been tested over a timeframe of 14 years in the studies presented in this article. The objective of the studies was to investigate the pharmacokinetics and the pharmacodynamics of follicle-stimulating hormone (FSH) after single subcutaneous and intramuscular doses and multiple subcutaneous doses of the tested preparations in healthy fertile pituitary-suppressed women.
DESIGNS
We performed five open, randomised, crossover, single-dose bioequivalence and/or bioavailability studies and one open, multiple-dose, pharmacokinetics and pharmacodynamics study.
STUDY SUBJECTS AND TREATMENTS
The six studies included 121 healthy fertile women taking their usual combined oral contraceptives for 3 months before the study: Study 1: 300 international units (IU) of highly purified menotrophin as single subcutaneous and intramuscular doses. Study 2: 300 IU of highly purified menotrophin (test formulation vs. comparator) as single subcutaneous doses. Study 3: 300 IU of highly purified urofollitrophin (hp-FSH) (test formulation vs. comparator) as single subcutaneous doses. Study 4: 300 IU (2 × 150 IU vs. 4 × 75 IU) of hp-FSH as single subcutaneous doses. Study 5: 225 and 445 IU of hp-FSH as single subcutaneous doses. Study 6: daily 225 IU of hp-FSH as subcutaneous doses for 5 consecutive days.
MAIN OUTCOME MEASURES
The main outcome measures were the FSH pharmacokinetic parameters, estradiol concentrations, and the number and size of the follicles.
RESULTS
FSH after single subcutaneous and intramuscular injections of menotrophin or urofollitrophin attained a systemic peak (maximum) concentration (C ) that was on average consistent throughout the first four studies and ranged from 4.98 to 7.50 IU/L. The area under the plasma concentration-time curve (AUC) from administration to the last observed concentration time t (AUC) ranged from 409.71 to 486.16 IU/L·h and the elimination half-life (t ) ranged from 39.02 to 53.63 h. After multiple doses of urofollitrophin (225 IU) for 5 days, FSH attained a mean C of 14.93 ± 2.92 IU/L and had an AUC during the time interval τ between two consecutive doses at steady state (AUC) of 322.59 ± 57.92 IU/L·h, which was similar to the mean AUC after a single subcutaneous dose of 225 IU of urofollitrophin in study 5 (306.82 ± 68.37 IU/L·h).
CONCLUSIONS
In our studies, the intramuscular and subcutaneous routes of menotrophin were equivalent; both menotrophin and urofollitrophin were bioequivalent to their marketed reference; FSH kinetic parameters following injection of urofollitrophin were dose proportional and independent from the administered concentration; and multiple doses of FSH increased estradiol levels and enhanced growth of follicles with a good dose-response correlation. Local tolerability was excellent throughout the six studies.
Topics: Adult; Biological Availability; Contraceptives, Oral, Combined; Cross-Over Studies; Dose-Response Relationship, Drug; Estradiol; Female; Follicle Stimulating Hormone; Half-Life; Humans; Injections, Subcutaneous; Menotropins; Therapeutic Equivalency; Urofollitropin
PubMed: 27638053
DOI: 10.1007/s40261-016-0451-6 -
Computational and Mathematical Methods... 2022To ask lots of questions and try to find the truth about the medicine-based effectiveness of letrozole (LE) combined with human menopausal gonadotropin (HMG) in the...
Efficacy of Letrozole Combined with Urinary Gonadotropin for Ovulation Induction in Endocrine Abnormal Infertility Patients: A Retrospective Single-Center, Case-Control Study.
AIMS
To ask lots of questions and try to find the truth about the medicine-based effectiveness of letrozole (LE) combined with human menopausal gonadotropin (HMG) in the treatment of inability to have children crops patients with endocrine (things that are different from what is usually expected and the effect on ovulation-related chemicals produced by the body).
MATERIALS AND METHODS
A total of 160 unable to have children crops patients with endocrine things that are different from what is usually expected who were treated in our hospital from March 2019 to March 2022 were selected as the subjects of this look at how things were in the past study and were divided into instance of watching, making a statement group was treated with human menopausal gonadotropin on the basis of the control group. The differences in serum related to the process of making children, chemical produced by the body levels, ovarian function, and ovulation induction effect between the two groups were watched and compared.
RESULTS
After treatment, LH, FSH, PRL, and E in the observation group were better than those in the control group. The ovarian volume, follicle size, follicle diameter, and endometrial thickness of the two groups of patients were significantly improved, and the observation group was better than the control group. Significance is < 0.05. After treatment, the ovarian volume, follicle size, follicle diameter, and endometrial thickness in the two groups were significantly improved, and the observation group was better than the control group, and the difference was statistically significant ( < 0.05). The ovulation rate, pregnancy rate, singleton pregnancy rate, and multiple pregnancy rate of the observation group were higher than those of the control group, and the difference was statistically significant by the chi-square test ( < 0.05).
CONCLUSION
Letrozole can promote the improvement of sex hormones in infertile patients. After being combined with human menopausal gonadotropin treatment, the follicle development and ovulation of patients are significantly improved, and infertility is improved to a certain extent. It has a certain reference value in the clinical treatment of endocrine abnormal infertility.
Topics: Case-Control Studies; Child; Female; Gonadotropins; Humans; Infertility, Female; Letrozole; Menotropins; Ovulation Induction; Pregnancy; Retrospective Studies
PubMed: 35860181
DOI: 10.1155/2022/5363754 -
British Medical Journal May 1979A simple scheme of investigation and treatment to restore fertility in amenorrhoeic women is described. Fifty-nine patients with amenorrhoea not due to primary ovarian... (Review)
Review
A simple scheme of investigation and treatment to restore fertility in amenorrhoeic women is described. Fifty-nine patients with amenorrhoea not due to primary ovarian failure were treated variously as appropriate, mainly with clomiphene (25), bromocriptine (15), or human menopausal gonadotrophins (12), and six by diet to increase their weight. All ovulated, and by the end of the study 55 (93%) had conceived, 42 (71%) had delivered at least one surviving child, and five others (8%) were pregnant and awaiting delivery. Conception rates were 49% within two cycles of treatment and 66% within three cycles; using life-table method to standardise the cumulative conception rates by correcting for patients who did not continue as long as others in the study, the expected conception rate was 79% in six cycles, 94% in 12 cycles, and 98% after 16 cycles. The multiple pregnancy rate was 13% and abortion rate 22%. Delivery rate (for a viable baby) were 48% within 11 months of starting treatment and 53% within one year; expected rates were 76% in 18 months and 97% in two years. The results show that a relatively simple scheme of classifying amenorrhoeic disorders endocrinologically followed by treatment directed at inducing ovulation allows amenorrhoeic women without primary ovarian failure to achieve conception and delivery rates equal to those in normal women.
Topics: Adult; Amenorrhea; Body Weight; Bromocriptine; Clomiphene; Female; Fertility; Fertility Agents, Female; Fertilization; Humans; Menotropins; Ovulation Induction; Pregnancy; Pregnancy, Multiple; Time Factors
PubMed: 378318
DOI: 10.1136/bmj.1.6173.1257 -
Fertility and Sterility Dec 1992To compare the in vitro fertilization and embryo transfer (IVF-ET) outcome of a 3-day gonadotropin-releasing hormone agonist (GnRH-a) administration: ultrashort protocol... (Comparative Study)
Comparative Study
OBJECTIVE
To compare the in vitro fertilization and embryo transfer (IVF-ET) outcome of a 3-day gonadotropin-releasing hormone agonist (GnRH-a) administration: ultrashort protocol with the outcome of long-acting GnRH-a cycles or human menopausal gonadotropin (hMG) alone.
DESIGN
Ninety-two cycles of the ultrashort protocol were matched with 92 cycles with long GnRH-a and with 92 hMG cycles.
SETTING
The IVF-ET program.
MAIN OUTCOME MEASURES
Amount and duration of hMG treatment, hormonal profile on the day of human chorionic gonadotropin administration, cancellation rate, number of oocytes retrieved, and fertilization and pregnancy rates (PRs) were examined and compared among the three groups.
RESULTS
The ultrashort group needed a higher number of hMG ampules than the hMG group but significantly less than in the long GnRH-a regimen. The number of oocytes in the ultrashort protocol was the same as in the long GnRH-a, but the number of embryos per retrieval was significantly lower than with the long GnRH-a protocol and similar to that found in the hMG group. The ultrashort protocol yielded 10% PR per cycle and 17% per replacement, significantly lower than with the long GnRH-a protocol, 26% and 36%, respectively, but also lower than in the hMG one, namely 13% and 28%.
CONCLUSION
The ultrashort protocol, although being convenient and having some advantages found in the long GnRH-a protocol, is inferior in its outcome compared with the two other protocols.
Topics: Chorionic Gonadotropin; Embryo Transfer; Estradiol; Female; Fertilization in Vitro; Gonadotropin-Releasing Hormone; Humans; Luteinizing Hormone; Menotropins; Progesterone; Triptorelin Pamoate
PubMed: 1459267
DOI: 10.1016/s0015-0282(16)55563-0 -
Fertility and Sterility Feb 1988In an effort to overcome possible interference by endogenous gonadotropin-ovarian hormone dynamics, desensitization of the pituitary gonadotropins by a...
In an effort to overcome possible interference by endogenous gonadotropin-ovarian hormone dynamics, desensitization of the pituitary gonadotropins by a gonadotropin-releasing hormone agonist (GnRHa) was achieved in 12 women with repeatedly failed attempts at multiple follicular stimulation. Eight women were scheduled for in vitro fertilization (IVF) and embryo transfer (ET), and 4 for gamete intrafallopian transfer (GIFT). Stimulation failure was characterized by premature luteinization, poor estradiol (E2) response, or inadequate follicular growth. The agonist was administered by nasal spray 500 to 600 micrograms/day beginning on days 21 to 23 of the menstrual cycle. A rapid desensitization occurred by 7.6 +/- 0.6 days (mean +/- standard error [SE]) following the initial dose. Gonadotropin stimulation was begun when pituitary and ovarian suppression was judged to be adequate. In response to gonadotropin stimulation, a continuous rise of E2 was observed in all patients with a mean of 989 +/- 46 pg/ml on the day of hCG. A cohort of synchronized follicles was recruited and matured. The mean number of growing follicles per patient was significantly higher (P less than 0.0001) in combined therapy than in previously failed cycles (8.0 +/- 0.3 versus 3.2 +/- 0.1). All the patients underwent oocyte retrieval and 94.3% of the harvested oocytes were preovulatory. A high fertilization rate (89.7%) of the inseminated oocytes occurred in IVF patients.
Topics: Adult; Buserelin; Embryo Transfer; Female; Fertilization in Vitro; Humans; Menotropins; Ovulation Induction; Reproductive Techniques
PubMed: 3123277
DOI: 10.1016/s0015-0282(16)59718-0 -
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