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

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ClinicalTrials.gov Identifier: NCT02140515
Recruitment Status : Unknown
Verified August 2012 by Royan Institute.
Recruitment status was:  Recruiting
First Posted : May 16, 2014
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Lutropin alfa Drug: Follitropin alfa and Lutropin alfa Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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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 Name: 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)


Outcome Measures
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Primary Outcome Measures :
  1. number of follicles [ Time Frame: baseline ]
    Evaluation thre number follicles before injection of Human Chorionic Gonadotrophin (hCG)

  2. Size of follicle [ Time Frame: baseline ]
    Evaluation the size of follicle before injection of Human Chorionic Gonadotrophin (hCG)

  3. Endometrial thickness [ Time Frame: 1day ]
    Evaluation the endometrial thickness at the day of injection of Human Chorionic Gonadotrophin (hCG)


Secondary Outcome Measures :
  1. number of oocytes retrieved [ Time Frame: 3 days ]
    Evaluation the number of oocytes retrieved 34-36 hours after Human Chorionic Gonadotrophin (hCG) injection

  2. Fertilization rate [ Time Frame: 2 days ]
    Evaluation the fertilization rate 2-3 days before the embryo transfer

  3. Biochemical pregnancy rate [ Time Frame: 2 weeks ]
    Evaluation the biochemical pregnancy rate 2 weeks after embryo transfer

  4. Clinical pregnancy rate [ Time Frame: 4 weeks ]
    Evaluation the clinical pregnancy rate 4-6 weeks after embryo transfer

  5. Implantation rate [ Time Frame: 4 weeks ]
    Evaluation the implantation rate 4-6 weeks after embryo transfer.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140515


Contacts
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Contact: Nasser Aghdami, MD,PhD (+98)2123562000 ext 516 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)2123562000 ext 414 Leara91@gmail.com

Locations
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Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    (+98)2123562000 ext 516    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, m    (+98)23562000 ext 414    Leara91@gmail.com   
Sub-Investigator: Reza Khalili, PhD         
Sub-Investigator: Jhaleh Etminan, Bsc         
Sub-Investigator: sdamaneh Jalali, BSc         
Sponsors and Collaborators
Royan Institute
Investigators
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Study Chair: Hamid Gourabi, PhD Head of Royan Institute
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
More Information
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Additional Information:

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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02140515    
Other Study ID Numbers: royan-Emb-018
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: August 2012
Keywords provided by Royan Institute:
Gonal-F Luveris Assisted Reproductive Technology Hypogonadotropic Hypogonadism
Additional relevant MeSH terms:
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Infertility
Hypogonadism
Genital Diseases
Urogenital Diseases
Gonadal Disorders
 Endocrine System Diseases
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs