Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation in Patients With Hypogonadotropic Hypogonadism

Phase 4

• Conditions: Infertility
• Interventions: Drug: Follitropin alfa and Lutropin alfa; Drug: Lutropin alfa

• Registration Number: NCT02140515
• Lead Sponsor: Royan Institute

Brief Summary

We wanted to compare the Assisted Reproductive Technology (ART) outcomes between two protocols of induction of ovulation in patients with Hypogonadotropic Hypogonadism. In the beginning, all patients receive Recombinant Follicle Stimulating Hormone (Gonal-F) and Recombinant Luteinizing Hormone (Luveris). When at least one follicle reaches 14 mm in diameter, Luveris alone is administered for group A and both drugs Gonal-F and Luveris for group B. Finally Assisted Reproductive Technology (ART) results are compared between the two groups.

Detailed Description

In this single blind randomized clinical trial, 90 women with a clinical history of hypogonadotrophic hypogonadism who stopped any treatment with gonadotrophins \>1 month before study, with a negative progesterone challenge test, low serum gonadotrophins (Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) less than 5.0 IU/l) and oestradiol (less than 100 pg/ml) and normal serum concentrations of thyroid stimulating hormone (TSH), testosterone and prolactin within 6 months before the start of treatment are studied in the Royan Institute. Other causes of infertility are excluded from the study. All patients receive treatment with recombinant follicle stimulating hormone (Gonal-F) and recombinant luteinizing hormone (Luveris). When at least one follicle reaches 14 mm in diameter, 4mg/day oestradiol is administered and patients are randomly divided into two groups: Luveris alone (intervention group) and continued treatment with both drugs Gonal-F and Luveris (control group). When at least one follicle detects a mean diameter of ≥18 mm and serum estradiol level reaches 500-2000 pg/ml, ovarian stimulation is stopped and injection of 10000 IU Human Chorionic Gonadotrophin (hCG) is administrated.

At the end, the number and size of ovarian follicles, endometrial thickness on the day of injection of Human Chorionic Gonadotrophin (hCG), the number of oocytes retrieved, the number of good quality embryos, chemical and clinical pregnancy rate, fertilization rate and implantation rate will be compared between the two groups.

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-11
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-16
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06
• Primary Completion: 2015-12
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism
• Have discontinued gonadotropins or gonadotropin releasing hormone or estrogen-progesterone replacement therapy at least one month before the study
• Have primary or secondary amenorrhea
• Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) <5.0 IU/l and oestradiol <100 pg/ml before initiation of treatment
• Have a negative progesterone challenge test
• Normal serum concentrations of thyroid stimulating hormone (TSH), prolactin and testosterone within 6 months before the start of study
• Be willing and able to comply with the protocol for the duration of the study
• Have given written informed consent prior to any study related procedure

Exclusion Criteria

• The other causes of infertility.
• History of ovarian hyper stimulation syndrome
• Abnormal gynecological bleeding of undetermined origin
• Previous or current hormone dependent tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gonal-F& Luveris	Follitropin alfa and Lutropin alfa	Evaluation the effect of Gonal-F\& Luveris protocols of Induction of ovulation in Patients with Hypogonadotropic Hypogonadism
Luveris	Lutropin alfa	Evaluation the effect of Luveris protocol on Induction of ovulation in Patients with Hypogonadotropic Hypogonadism

Primary Outcome Measures

Name	Time	Method
number of follicles	baseline	Evaluation thre number follicles before injection of Human Chorionic Gonadotrophin (hCG)
Size of follicle	baseline	Evaluation the size of follicle before injection of Human Chorionic Gonadotrophin (hCG)
Endometrial thickness	1day	Evaluation the endometrial thickness at the day of injection of Human Chorionic Gonadotrophin (hCG)

Secondary Outcome Measures

Name	Time	Method
number of oocytes retrieved	3 days	Evaluation the number of oocytes retrieved 34-36 hours after Human Chorionic Gonadotrophin (hCG) injection
Fertilization rate	2 days	Evaluation the fertilization rate 2-3 days before the embryo transfer
Clinical pregnancy rate	4 weeks	Evaluation the clinical pregnancy rate 4-6 weeks after embryo transfer
Implantation rate	4 weeks	Evaluation the implantation rate 4-6 weeks after embryo transfer.
Biochemical pregnancy rate	2 weeks	Evaluation the biochemical pregnancy rate 2 weeks after embryo transfer

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of