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

May 5, 2015 updated by: Royan Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Royan Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Reza Khalili, PhD
        • Sub-Investigator:
          • Jhaleh Etminan, Bsc
        • Sub-Investigator:
          • sdamaneh Jalali, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Luveris
Evaluation the effect of Luveris protocol on Induction of ovulation in Patients with Hypogonadotropic Hypogonadism
Drug: Lutropin alfa
Administration of Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)
Other Names:
  • Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)
Active Comparator: Gonal-F& Luveris
Evaluation the effect of Gonal-F& Luveris protocols of Induction of ovulation in Patients with Hypogonadotropic Hypogonadism
Drug: Follitropin alfa and Lutropin alfa
Administration of (rFSH) and (rLH)
Other Names:
  • Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH) and
  • Lutropin alfa: Luveris or Recombinant Luteinizing Hormone (rLH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of follicles
Time Frame: baseline
Evaluation thre number follicles before injection of Human Chorionic Gonadotrophin (hCG)
baseline
Size of follicle
Time Frame: baseline
Evaluation the size of follicle before injection of Human Chorionic Gonadotrophin (hCG)
baseline
Endometrial thickness
Time Frame: 1day
Evaluation the endometrial thickness at the day of injection of Human Chorionic Gonadotrophin (hCG)
1day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Study Director: Tahereh Madani, MD, Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
  • Principal Investigator: Seyedeh Masoumeh Moosavi Sadat, MSc, Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • royan-Emb-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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