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

NCT02140515 | Unknown Phase 4 DMC

• 1 other identifier: royan-Emb-018
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Gonal-F Luveris Assisted Reproductive Technology Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (3)

• number of follicles

  Evaluation thre number follicles before injection of Human Chorionic Gonadotrophin (hCG)

  baseline

• Size of follicle

  Evaluation the size of follicle before injection of Human Chorionic Gonadotrophin (hCG)

  baseline

• Endometrial thickness

  Evaluation the endometrial thickness at the day of injection of Human Chorionic Gonadotrophin (hCG)

  1day

Secondary Outcomes (5)

• number of oocytes retrieved

  3 days

• Fertilization rate

  2 days

• Biochemical pregnancy rate

  2 weeks

• Clinical pregnancy rate

  4 weeks

• Implantation rate

  4 weeks

Study Arms (2)

Luveris

ACTIVE COMPARATOR

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

Drug: Lutropin alfa

Gonal-F& Luveris

ACTIVE COMPARATOR

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

Drug: Follitropin alfa and Lutropin alfa

Interventions

Lutropin alfa DRUG

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

Also known as: Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)

Luveris

Follitropin alfa and Lutropin alfa DRUG

Administration of (rFSH) and (rLH)

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

Gonal-F& Luveris

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Interventions

Luteinizing Hormone, beta Subunit; Glycoprotein Hormones, alpha Subunit; follitropin alfa; Luteinizing Hormone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Chorionic Gonadotropin; Follicle Stimulating Hormone; Thyrotropin; Placental Hormones

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Tahereh Madani, MD

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

  STUDY DIRECTOR

• Seyedeh Masoumeh Moosavi Sadat, MSc

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasser Aghdami, MD,PhD

CONTACT

(+98)2123562000; nasser.aghdami@royaninstitute.org

Leila Arab, MD

CONTACT

(+98)2123562000; Leara91@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 16, 2014
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: November 1, 2016
• Last Updated: May 6, 2015

Record last verified: 2012-08

Locations

IR (1)