Androgenic Profile Following Controlled Ovarian Stimulation

NCT02992808 | Unknown Phase 4

• 1 other identifier: SHEBA-16-3516-EZ-CTIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study the investigators will try to discover whether there is a difference for any of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris \& luveris) vs. human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of androgenic hormones profile. The study question is whether using recombinant LH will result in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using highly purified urinary gonadotropins with hCG mimicking LH activity.

Conditions

Infertility, Female

Keywords

IVF; Ovarian stimulation; Androgenic profile; Follicular fluid; Recombinant gonadotropins; human menopausal gonadotropin

Outcome Measures

Primary Outcomes (2)

• Serum hormonal profile

  Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone

  (1) day 1-3 of menstruation (Day-S); (2) day of or prior to hCG administration (Day-hCG); and (3) day of ovum pick-up (Day-OPU).

• Follicular fluid hormonal profile

  Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone

  Ovum pick up day

Secondary Outcomes (9)

• Implantation rate

  About three weeks after embryo transfer

• Clinical pregnancy

  About three weeks after embryo transfer

• Biochemical pregnancy

  About two weeks after embryo tranfer

• Ongoing pregnancy

  10-12 weeks after embryo tranfer

• Live birth rate

  Until about 40 weeks after embryo transfer

Study Arms (2)

Recombinant preparations

ACTIVE COMPARATOR

Drug: recombinant gonadotropins

HP-HMG

ACTIVE COMPARATOR

Highly purified human menopausal gonadotropin

Drug: HP-HMG

Interventions

recombinant gonadotropins DRUG

Also known as: Pergoveris & Luveris

Recombinant preparations

HP-HMG DRUG

Also known as: Menopur

HP-HMG

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile women between 20-40 years of age
• BMI 19-35
• undergoing their 1-4 IVF cycle

You may not qualify if:

• Suspected PCOS
• History of OHSS
• Patients who had a chronic illness or were receiving chronic medical treatment

Sponsors & Collaborators

• Sheba Medical Center: lead

Related Publications (5)

• Andersen AN, Devroey P, Arce JC. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Hum Reprod. 2006 Dec;21(12):3217-27. doi: 10.1093/humrep/del284. Epub 2006 Jul 27.

  PMID: 16873892 BACKGROUND

• Devroey P, Pellicer A, Nyboe Andersen A, Arce JC; Menopur in GnRH Antagonist Cycles with Single Embryo Transfer Trial Group. A randomized assessor-blind trial comparing highly purified hMG and recombinant FSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer. Fertil Steril. 2012 Mar;97(3):561-71. doi: 10.1016/j.fertnstert.2011.12.016. Epub 2012 Jan 13.

  PMID: 22244781 BACKGROUND

• Van Wely M, Westergaard LG, Bossuyt PM, Van der Veen F. Human menopausal gonadotropin versus recombinant follicle stimulation hormone for ovarian stimulation in assisted reproductive cycles. Cochrane Database Syst Rev. 2003;(1):CD003973. doi: 10.1002/14651858.CD003973.

  PMID: 12535497 BACKGROUND

• Requena A, Cruz M, Ruiz FJ, Garcia-Velasco JA. Endocrine profile following stimulation with recombinant follicle stimulating hormone and luteinizing hormone versus highly purified human menopausal gonadotropin. Reprod Biol Endocrinol. 2014 Jan 29;12:10. doi: 10.1186/1477-7827-12-10.

  PMID: 24476504 BACKGROUND

• Revelli A, Pettinau G, Basso G, Carosso A, Ferrero A, Dallan C, Canosa S, Gennarelli G, Guidetti D, Filippini C, Benedetto C. Controlled Ovarian Stimulation with recombinant-FSH plus recombinant-LH vs. human Menopausal Gonadotropin based on the number of retrieved oocytes: results from a routine clinical practice in a real-life population. Reprod Biol Endocrinol. 2015 Jul 25;13:77. doi: 10.1186/s12958-015-0080-6.

  PMID: 26209525 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Interventions

pergoveris; Luteinizing Hormone, beta Subunit; Menotropins

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Luteinizing Hormone; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Central Study Contacts

Eran Zilberberg, MD

CONTACT

+97235302882

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician, Infertility & IVF Unit, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: December 11, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2020
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share