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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Luveris

Evaluation the effect of Luveris protocol on Induction of ovulation in Patients with Hypogonadotropic Hypogonadism

Group Type ACTIVE_COMPARATOR

Lutropin alfa

Intervention Type DRUG

Administration of Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)

Gonal-F& Luveris

Evaluation the effect of Gonal-F\& Luveris protocols of Induction of ovulation in Patients with Hypogonadotropic Hypogonadism

Group Type ACTIVE_COMPARATOR

Follitropin alfa and Lutropin alfa

Intervention Type DRUG

Administration of (rFSH) and (rLH)

Interventions

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Lutropin alfa

Administration of Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)

Intervention Type DRUG

Follitropin alfa and Lutropin alfa

Administration of (rFSH) and (rLH)

Intervention Type DRUG

Other Intervention Names

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Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH) Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH) and Lutropin alfa: Luveris or Recombinant Luteinizing Hormone (rLH)

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Tahereh Madani, MD

Role: STUDY_DIRECTOR

Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

Seyedeh Masoumeh Moosavi Sadat, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran