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Fertility and Sterility Aug 2020To evaluate the efficacy and safety of highly purified human menotropin (HP-hMG) and recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation... (Comparative Study)
Comparative Study
Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection.
OBJECTIVE
To evaluate the efficacy and safety of highly purified human menotropin (HP-hMG) and recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation in a population of patients predicted to be high responders.
DESIGN
Randomized, open-label, assessor-blinded, parallel-group, noninferiority trial.
SETTING
Fertility centers.
PATIENT(S)
A total of 620 women with serum antimüllerian hormone (AMH) ≥5 ng/mL.
INTERVENTION(S)
Controlled ovarian stimulation with HP-hMG or rFSH in a GnRH antagonist assisted reproductive technology (ART) cycle. Fresh transfer of a single blastocyst was performed unless ovarian response was excessive, in which all embryos were cryopreserved. Subjects could undergo subsequent frozen blastocyst transfer within 6 months of randomization.
MAIN OUTCOME MEASURE(S)
Ongoing pregnancy rate (OPR) after fresh transfer (primary endpoint), as well as cumulative live birth, ovarian hyperstimulation syndrome (OHSS), and pregnancy loss rates.
RESULTS
OPR/cycle start after fresh transfer was 35.5% with HP-hMG and 30.7% with rFSH (difference: 4.7%, 95% CI -2.7%, 12.1%); noninferiority was established. Compared to rFSH, HP-hMG was associated with significantly lower OHSS (21.4% vs. 9.7% respectively; difference: -11.7%, 95% CI -17.3%, -6.1%) and cumulative early pregnancy loss rates (25.5% vs. 14.5% respectively; difference: -11.0%, 95% CI -18.8%, -3.14%). Despite 43 more transfers in the rFSH group, cumulative live birth rates were similar with HP-hMG and rFSH at 50.6% and 51.5% respectively (difference: -0.8%, 95% CI -8.7%, 7.1%).
CONCLUSION(S)
In high responders, HP-hMG provided comparable efficacy to rFSH with fewer adverse events, including pregnancy loss, suggesting its optimized risk/benefit profile in this population.
CLINICAL TRIAL REGISTRATION NUMBER
NCT02554279 (clinicaltrials.gov).
Topics: Abortion, Spontaneous; Adult; Anti-Mullerian Hormone; Biomarkers; Female; Fertility; Fertility Agents, Female; Follicle Stimulating Hormone, Human; Humans; Infertility; Live Birth; Male; Menotropins; Ovarian Hyperstimulation Syndrome; Ovary; Ovulation; Ovulation Induction; Pregnancy; Pregnancy Rate; Prospective Studies; Recombinant Proteins; Single Embryo Transfer; Sperm Injections, Intracytoplasmic; Treatment Outcome; United States; Young Adult
PubMed: 32416978
DOI: 10.1016/j.fertnstert.2020.03.029 -
Fertility and Sterility Aug 2020
Topics: Follicle Stimulating Hormone; HIV Infections; Humans; Menotropins; Sperm Injections, Intracytoplasmic; Viral Load
PubMed: 32624220
DOI: 10.1016/j.fertnstert.2020.04.019 -
Reproductive Biology and Endocrinology... Oct 2009Over the last several decades, as a result of an evolution in manufacturing processes, a marked development has been made in the field of gonadotropins for ovarian... (Comparative Study)
Comparative Study
BACKGROUND
Over the last several decades, as a result of an evolution in manufacturing processes, a marked development has been made in the field of gonadotropins for ovarian stimulation. Initially, therapeutic gonadotropins were produced from a simple process of urine extraction and purification; now they are produced via a complex system involving recombinant technology, which yields gonadotropins with high levels of purity, quality, and consistency.
METHODS
A retrospective analysis of 865 consecutive intracytoplasmic sperm injection (ICSI) cycles of controlled ovarian hyperstimulation (COH) compared the clinical efficacy of three gonadotropins (menotropin [hMG; n = 299], highly-purified hMG [HP-hMG; n = 330] and follitropin alfa [r-hFSH; n = 236]) for ovarian stimulation after pituitary down-regulation. The endpoints were live birth rates and total doses of gonadotropin per cycle and per pregnancy.
RESULTS
Laboratory and clinical protocols remained unchanged over time, except for the type of gonadotropin used, which was introduced sequentially (hMG, then HP-hMG, and finally r-hFSH). Live birth rates were not significantly different for hMG (24.4%), HP-hMG (32.4%) and r-hFSH (30.1%; p = 0.09) groups. Total dose of gonadotropin per cycle was significantly higher in the hMG (2685 +/- 720 IU) and HP-hMG (2903 +/- 867 IU) groups compared with the r-hFSH-group (2268 +/- 747 IU; p < 0.001). Total dose of gonadotropin required to achieve clinical pregnancy was 15.7% and 11.0% higher for the hMG and HP-hMG groups, respectively, compared with the r-hFSH group, and for live births, the differences observed were 45.3% and 19.8%, respectively.
CONCLUSION
Although similar live birth rates were achieved, markedly lower doses of r-hFSH were required compared with hMG or HP-hMG.
Topics: Adult; Female; Follicle Stimulating Hormone, Human; Glycoprotein Hormones, alpha Subunit; Humans; Infertility, Male; Male; Menotropins; Pregnancy; Pregnancy Outcome; Retrospective Studies; Sperm Injections, Intracytoplasmic; Treatment Outcome; Ultrafiltration
PubMed: 19828024
DOI: 10.1186/1477-7827-7-111 -
Fertility and Sterility Oct 1987Women who conceive with human gonadotropins have a high rate of spontaneous abortions. The causes for this poor outcome are unknown. In a retrospective analysis, the...
Women who conceive with human gonadotropins have a high rate of spontaneous abortions. The causes for this poor outcome are unknown. In a retrospective analysis, the authors analyzed potential factors in 45 menotropin-treated patients with spontaneous first-trimester miscarriages. Data were compared with 119 menotropin-treated patients who conceived and delivered viable infants. Patient factors that were analyzed included the following: age, history of past miscarriages, duration of infertility, diagnostic category, weight, body surface area, duration and weight-corrected dose of menotropin administration, maximum estradiol level, estradiol pattern, human chorionic gonadotropin (hCG) dose, presence or absence of hCG support in the luteal phase, results of postcoital testing, methods of insemination, and results of husband's semen analysis. There was a significant difference between the miscarriage group and the control group in regard to age and weight distribution. All other characteristics were not significantly different. Patients over 81.8 kg as well as patients aged 35 years and older were both significantly (P less than 0.01) at increased risk to have a spontaneous first-trimester miscarriage. The data suggest that obesity and advanced age contribute to the high miscarriage rate in menotropin-treated patients. It appears reasonable to suggest that women weighing more than 81.8 kg should make every effort to lose weight before beginning menotropin therapy.
Topics: Abortion, Spontaneous; Adult; Age Factors; Body Weight; Chorionic Gonadotropin; Estradiol; Female; Humans; Infertility; Menotropins; Pregnancy; Retrospective Studies; Risk Factors
PubMed: 3115834
DOI: 10.1016/s0015-0282(16)59466-7 -
BioMed Research International 2022The endometrium receptivity was impaired by controlled ovarian hyperstimulation (COH), which would then lead to fertility issues and increased abortion clinically. In...
The endometrium receptivity was impaired by controlled ovarian hyperstimulation (COH), which would then lead to fertility issues and increased abortion clinically. In the present study, to explore the effectiveness of Tiaojing Zhuyun Formula (TJZYF) in improving endometrial receptivity of COH rats and the possible active ingredients and mechanisms, an approach of network pharmacology was performed and a COH animal model was established. As analyzed, stigmasterol and quercetin may be the active ingredients of TJZYF on improving endometrial receptivity and positive regulation of ion transport, the cytokine-mediated signaling pathway, and endocrine process, and vascular endothelial growth factor receptor signaling pathway may be involved. Eighty female rats were divided into four groups randomly: control, model, TJZYF, and TJZYF+si-VEGFA. COH rat models were constructed by injecting with human menopausal gonadotropin (HMG) and human chorionic gonadotropin (HCG). We found that both endometrial thickness and number of embryo implantations in model were substantially reduced vs. control. The gene and protein expressions of VEGF, PI3K, and p-Akt in the uterus were significantly reduced. TJZYF could increase the endometrial thickness and number of embryo implantations and enhance the expressions of VEGF, PI3K, and p-Akt in the uterus. In the TJZYF+si-VEGFA group, the effect of TJZYF was impaired. Generally, TJZYF could improve the endometrium receptivity and facilitate embryo implantation of COH rats by upregulating VEGF and enhancing the PI3K/Akt signaling pathway.
Topics: Animals; Female; Pregnancy; Rats; Chorionic Gonadotropin; Cytokines; Embryo Implantation; Endometrium; Menotropins; Phosphatidylinositol 3-Kinases; Proto-Oncogene Proteins c-akt; Quercetin; Receptors, Vascular Endothelial Growth Factor; Signal Transduction; Stigmasterol; Vascular Endothelial Growth Factor A
PubMed: 36193314
DOI: 10.1155/2022/9212561 -
American Journal of Obstetrics and... Sep 2018
Topics: Endocrinology; Fertility Agents, Female; History, 20th Century; History, 21st Century; Infertility; Menotropins; Reproductive Medicine
PubMed: 30170793
DOI: 10.1016/j.ajog.2018.06.019 -
Fertility and Sterility Mar 1991The risks of menotropin therapy (ovarian hyperstimulation syndrome, multiple gestation, adnexal torsion) are well known and have been previously described.... (Review)
Review
The risks of menotropin therapy (ovarian hyperstimulation syndrome, multiple gestation, adnexal torsion) are well known and have been previously described. Superovulation should not be considered for the indications described herein until more traditional therapies for infertility have been tried and found unsuccessful and sufficient time has elapsed for conception to occur. The cost of superovulation is high: the medications are expensive, frequent E2 monitoring and US studies are costly, and pregnancy complications relating to the higher rate of pregnancy loss and multiple gestation may add substantially to the overall cost. Yet, compared with IVF and GIFT, superovulation cycles combined with IUI cost between one third to one sixth that of an IVF cycle. Protocols involving combined CC/hMG/hCG, which reduce the total number of ampules of Pergonal needed per cycle and still provide multiple follicular development, may further reduce costs. There is a growing consensus that superovulation-IUI protocols should be attempted before GIFT and IVF in couples with normal pelvic viscera. There is little doubt that IVF and GIFT cycles are more costly, stressful, and complex. No comparative data have clearly shown IVF and GIFT to be superior to superovulation protocols in ovulatory women with normal pelvic anatomy. In the only study examining this issue published to date, Kaplan et al. retrospectively analyzed all GIFT and superovulation/IUI cycles at a single university center and found GIFT to be three times more efficient. However, the inherent limitations of a nonrandomized, nonprospective study of this kind are obvious as these authors have suggested. Therefore, it may be wise to consider the use of superovulation before assisted reproductive technologies until this issue is settled. It would be interesting to determine if the high PRs reported for couples with unexplained infertility or mild endometriosis in IVF and GIFT cycles in some centers not incorporating superovulation/IUI protocols would hold up if such an approach was routinely followed. Despite the increasing acceptance of superovulation protocols, we must be aware that many of the studies suggesting a role of hMG in treating ovulatory infertile women with normal pelvic anatomy suffer from deficiencies in experimental design. In a payor-driven system, such as in the United States, the difficulties in designing and carrying out scientifically sound clinical studies examining infertility therapies are obvious. The lack of federal or outside funding for the study of infertility issues contributes to the problem. It is our hope that better designed studies examining the role of superovulation in the treatment of ovulatory infertile women with normal pelvic anatomy will be forthcoming.
Topics: Female; Humans; Infertility; Male; Menotropins; Ovarian Follicle; Ovulation Induction; Superovulation
PubMed: 1900476
DOI: 10.1016/s0015-0282(16)54169-7 -
Fertility and Sterility May 2004
Topics: Drug Costs; Female; Fertility Agents, Female; Fertilization in Vitro; Follicle Stimulating Hormone; Humans; Male; Menotropins; Randomized Controlled Trials as Topic; Recombinant Proteins; Research Design; Sperm Injections, Intracytoplasmic
PubMed: 15136121
DOI: 10.1016/j.fertnstert.2004.03.003 -
Fertility and Sterility Sep 1982
Topics: Adult; Coitus; Ethinyl Estradiol; Female; Humans; Infertility, Female; Menotropins
PubMed: 6811335
DOI: 10.1016/s0015-0282(16)46530-1 -
Fertility and Sterility Aug 1987
Topics: Adult; Cervix Mucus; Chorionic Gonadotropin; Chorionic Gonadotropin, beta Subunit, Human; Fallopian Tubes; Female; Humans; Insemination, Artificial; Insemination, Artificial, Homologous; Male; Menotropins; Ovulation Induction; Peptide Fragments; Pregnancy; Sperm Agglutination; Sperm Motility; Spermatozoa
PubMed: 2440731
DOI: 10.1016/s0015-0282(16)59367-4