Clinical trial NCT01669291: Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation
Official title: Effect of GnRH Antagonist Protocol vs Agonist Long Protocol During Controlled Hyperstimulation (COH)for Assisted Reproduction on IVF Outcome, Peak Estradiol Level, and Duration of Stimulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility
Lead sponsor: Main Line Fertility Center
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2012-08-21
Enrollment: 43
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.

Detailed description: No detailed description

Eligibility criteria: Inclusion Criteria:

* Ages 21-40 (inclusive up to 41)
* Day 2-4 FSH \< or equal to 10
* Antimullerian Hormone (AMH) greater than or equal to 1.0
* Between 5 and 20 antral follicles on day 2-4
* Body Mass Index (BMI)\>or equal to 18 and \< or equal to 32

Exclusion Criteria:

* Smokers
* Polycystic Ovarian Disease
* Endometriosis greater than Stage I
* Testicular aspirated sperm

Primary outcomes:
measure: To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist.
timeFrame: One year
Secondary outcomes:
measure: To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist
timeFrame: One year
measure: To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist.
timeFrame: One year
Other outcomes:
Locations:
city: Bryn Mawr
country: United States
facility: Main Line Fertility Center
state: Pennsylvania
Study officials:
affiliation: Main Line Fertility Center
name: Michael J Glassner, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Main Line Fertility Center
name: Sharon H. Anderson, Ph.D
role: STUDY_DIRECTOR
References:
citation: Ludwig, Michael. GnRH antagonists. Textbook of Assisted Reproductive Technologies - Laboratory and Clinical Perspectives. Third edition. Edited by Gardner, D, Weissman, A, Howles, C, Shoham, Z. 2009: 539-552.
citation: Ludwig M, Katalinic A, Diedrich K. Use of GnRH antagonists in ovarian stimulation for assisted reproductive technologies compared to the long protocol. Meta-analysis. Arch Gynecol Obstet. 2001 Nov;265(4):175-82. doi: 10.1007/s00404-001-0267-2.
citation: Fluker M, Grifo J, Leader A, Levy M, Meldrum D, Muasher SJ, Rinehart J, Rosenwaks Z, Scott RT Jr, Schoolcraft W, Shapiro DB; North American Ganirelix Study Group. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril. 2001 Jan;75(1):38-45. doi: 10.1016/s0015-0282(00)01638-1.
citation: Ludwig M, Felberbaum RE, Devroey P, Albano C, Riethmuller-Winzen H, Schuler A, Engel W, Diedrich K. Significant reduction of the incidence of ovarian hyperstimulation syndrome (OHSS) by using the LHRH antagonist Cetrorelix (Cetrotide) in controlled ovarian stimulation for assisted reproduction. Arch Gynecol Obstet. 2000 Jul;264(1):29-32. doi: 10.1007/pl00007479.