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

Infertility Clinical Trial

Official title:

Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation by Using Recombinant Luteinizing Hormone (rLH) and Recombinant Follicle Stimulating Hormone (rFSH) in Patients With Hypogonadotropic Hypogonadism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02140515
• Other study ID #: royan-Emb-018
• Status: Recruiting
• Phase: Phase 4
• First received: May 14, 2014
• Last updated: May 5, 2015
• Start date: November 2012
• Est. completion date: November 2016

Study information

• Verified date: August 2012
• Source: Royan Institute
• Contact: Nasser Aghdami, MD,PhD
• Phone: (+98)2123562000
• Email: nasser.aghdami[@]royaninstitute.org
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Infertility

Intervention

Drug:
• Lutropin alfa
Administration of Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)
• Follitropin alfa and Lutropin alfa
Administration of (rFSH) and (rLH)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of follicles	Evaluation thre number follicles before injection of Human Chorionic Gonadotrophin (hCG)	baseline	Yes
Primary	Size of follicle	Evaluation the size of follicle before injection of Human Chorionic Gonadotrophin (hCG)	baseline	Yes
Primary	Endometrial thickness	Evaluation the endometrial thickness at the day of injection of Human Chorionic Gonadotrophin (hCG)	1day	Yes
Secondary	number of oocytes retrieved	Evaluation the number of oocytes retrieved 34-36 hours after Human Chorionic Gonadotrophin (hCG) injection	3 days	Yes
Secondary	Fertilization rate	Evaluation the fertilization rate 2-3 days before the embryo transfer	2 days	Yes
Secondary	Biochemical pregnancy rate	Evaluation the biochemical pregnancy rate 2 weeks after embryo transfer	2 weeks	Yes
Secondary	Clinical pregnancy rate	Evaluation the clinical pregnancy rate 4-6 weeks after embryo transfer	4 weeks	Yes
Secondary	Implantation rate	Evaluation the implantation rate 4-6 weeks after embryo transfer.	4 weeks	Yes

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