Comparison of Human Menopausal Gonadotropins and the Combination of Human Menopausal Gonadotropins With Clomiphene Citrate in Stimulated Intrauterine Insemination Cycles
Study Details
Study Description
Brief Summary
The aim of study is to evaluate the results of two different protocols for ovulation induction during IUI cycles. All patients undergo IUI cycles are randomly divided in to two groups. the first group is human menopausal gonadotropins and the second group is the combination of human menopausal gonadotropins with clomiphene citrate
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Approximately %10-15 of couples of reproductive age, have infertility issues. %30-40 male factor, %40-50 female factor, and %20-25 both play a role in infertility etiology. Contributory factors of cases are %30-40 male factors, %40-50 female factors, and %20-25 mixed type. Ovulation induction and intrauterine insemination (IUI) are the main treatments for infertility. IUI is accepted as the most used treatment procedure according to other assisted reproductive techniques because it has lower costs, can be easily applied, and is less invasive. Clomiphene citrate is the most commonly used for ovulation induction, which is cheaper and has a lower incidence of multiple pregnancies. Controlled ovarian hyperstimulation with human menopausal gonadotropins and IUI has a higher incidence of pregnancy rates in an ovulation, unexplained and mild male factor infertility cases.
Data including age, BMI, smoking, the duration of infertility, the type of infertility, total motile sperm count (TMSS) of inseminated material and sperm morphology, antral follicle count, number of developed follicles and endometrial thickness on HCG day will be recorded. On the 2nd or 3rd day of the cycle, the patient will be randomized into two groups. Group 1 (HMG: n=127, 75 IU hMG/day), and Group 2 (clomiphene citrate 100 mg/day for 5 days following by 75 IU hMG/day; n=127). Human chorionic gonadotropin (hCG) will be used for trigger when the dominant follicle's diameter reaches 17-18mm for ovulation. Thirty-six hours after the hCG injection, single IUI will be performed by using the fresh sperm obtained by the density gradient method with a soft catheter in the dorsolithotomy position under ultrasound guidance. The patient will be kept supine position after the procedure for 15 minutes. After IUI, sexual intercourse will be recommended for three days. Intravaginal progesterone (LUTINUS® 100 mg vaginal tablet, Ferring GmbH Wittland/Kiel/Germany) to both groups will be used once a day after insemination for luteal phase support. Clinical pregnancy rates will be recorded by performing a blood test for on the 15th day after the procedure.
The aim of study is to evaluate the results of two different protocols for ovulation induction during IUI cycles. All patients undergo IUI cycles are randomly divided in to two groups. the first group is human menopausal gonadotropins and the second group is the combination of human menopausal gonadotropins with clomiphene citrate
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: human menopausal gonadotropins Menopur® (75 I.U., Ferring Pharmaceuticals, Kiel, Germany) |
Drug: human menopausal gonadotropin
clinical pregnancy rates
|
| Active Comparator: human menopausal gonadotropins and clomiphene citrate Menopur® (75 I.U., Ferring Pharmaceuticals, Kiel, Germany) Klomen® (50 mg, Koçak Farma, Tekirdag, Turkey) |
Drug: human menopausal gonadotropin and clomiphene citrate
clinical pregnancy rates
|
Outcome Measures
Primary Outcome Measures
- clinical pregnancy [day 15]
after iui betahcg levels blood sampling
Secondary Outcome Measures
- Ongoing pregnancy rate [Months 3]
Ongoing pregnancy rates 3 months after iui
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-40 years old female
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Unexplained infertility
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Regular menstrual cycle
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Bilateral tubal patency in HSG and normal uterine cavity
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Total motile sperm count greater than 10 million/ml
Exclusion Criteria:
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History of ovarian surgery
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Uncorrected uterine pathology
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Other endocrine diseases (thyroid, prolactin, hypogonadotropic hypogonadism)
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Presence of a cyst greater than 10 mm on USG in 2-3 days of the period
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Stage 3-4 endometriosis
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TMSS < 5 million/ml on the insemination day
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Conditions where HMG and clomiphene citrate are contraindicated
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bezmialem Vakif University | Istanbul | Turkey |
Sponsors and Collaborators
- Bezmialem Vakif University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Dankert T, Kremer JA, Cohlen BJ, Hamilton CJ, Pasker-de Jong PC, Straatman H, van Dop PA. A randomized clinical trial of clomiphene citrate versus low dose recombinant FSH for ovarian hyperstimulation in intrauterine insemination cycles for unexplained and male subfertility. Hum Reprod. 2007 Mar;22(3):792-7. doi: 10.1093/humrep/del441. Epub 2006 Nov 16.
- Erdem M, Abay S, Erdem A, Firat Mutlu M, Nas E, Mutlu I, Oktem M. Recombinant FSH increases live birth rates as compared to clomiphene citrate in intrauterine insemination cycles in couples with subfertility: a prospective randomized study. Eur J Obstet Gynecol Reprod Biol. 2015 Jun;189:33-7. doi: 10.1016/j.ejogrb.2015.03.023. Epub 2015 Mar 28.
- Peeraer K, Debrock S, De Loecker P, Tomassetti C, Laenen A, Welkenhuysen M, Meeuwis L, Pelckmans S, Mol BW, Spiessens C, De Neubourg D, D'Hooghe TM. Low-dose human menopausal gonadotrophin versus clomiphene citrate in subfertile couples treated with intrauterine insemination: a randomized controlled trial. Hum Reprod. 2015 May;30(5):1079-88. doi: 10.1093/humrep/dev062. Epub 2015 Mar 18.
- 07.12.2022-E.87948