Duration of GnRH-Analogue Downregulation and Pregnancy Rates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Aristotle University Of Thessaloniki.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00436319
First received: February 16, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

The purpose of this study is to assess whether the probability of pregnancy is dependent on the duration of GnRH agonist downregulation in IVF cycles.


Condition Intervention Phase
Infertility
Drug: GnRH agonists
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of the Duration of GnRH-Analogue Downregulation on Pregnancy Rates in IVF

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • pregnancy rate

Estimated Enrollment: 300
Study Start Date: May 2006
Estimated Study Completion Date: January 2007
Detailed Description:

GnRH agonists have been used extensively in assisted reproduction technologies for inhibition of gonadotropin secretion from the pituitary prior to initiation of ovarian stimulation. Administration of GnRH agonists results in the prevention of spontaneous LH surges, which lead to luteinization of the developing follicles, initiation of final oocyte maturation and a decrease in pregnancy rates.

GnRH agonists are usually administered according to two protocols: the short and long protocol.In the long protocol, downregulation with GnRH agonists is initiated either in the middle of the secretory phase, or at the beginning of the follicular phase. Stimulation of the ovaries with gonadotropins is initiated when downregulation is confirmed.

Administration of gonadotropins is usually started during the second or third week of treatment with GnRH agonists.The possibility of earlier initiation of the ovarian stimulation, if downregulation is confirmed at an earlier stage, has not been examined so far.

The purpose of this study is to assess whether the duration of pituitary downregulation with GnRH agonists, prior to initiation of ovarian stimulation with gonadotropins, has any effect on pregnancy rate, in women undergoing IVF.

  Eligibility

Ages Eligible for Study:   19 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age under 39
  • less than 3 previous IVF cycles
  • BMI 18-29
  • normal ultrasound of internal genital organs

Exclusion Criteria:

  • polycystic ovarian syndrome
  • endometriosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436319

Contacts
Contact: Efstratios Kolibianakis, MD PhD 00306937096078 stratis.kolibianakis@irg.gr
Contact: Lydia Kalogeropoulou, MD 0030 6974640068 lyd_kal@hotmail.com

Locations
Greece
Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece Recruiting
Thessaloniki, Greece
Contact: Efstratios M Kolibianakis, MD PhD    0030 6937 096 078    stratis.kolibianakis@irg.gr   
Principal Investigator: Lydia Kalogeropoulou, MD         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Basil C Tarlatzis, MD PhD Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00436319     History of Changes
Other Study ID Numbers: UHR-2
Study First Received: February 16, 2007
Last Updated: February 16, 2007
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Aristotle University Of Thessaloniki:
Infertility, downregulation, stimulation, agonists, long

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 29, 2014