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Duration of GnRH-analogue Downregulation and Pregnancy Rates

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
E.M. Kolibianakis, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00436319
First received: February 16, 2007
Last updated: February 11, 2016
Last verified: February 2016
  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
Procedure: Duration of GnRH agonist downregulation
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: May 2006
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
In the control group (group 1) the initiation of the ovarian stimulation will be realized according to the typical long luteal protocol, two weeks after the initiation of the GnRH agonist administration.
2
In the study group (group 2) the initiation of the ovarian stimulation will be effectuated on the second day of the menstrual period.
Procedure: Duration of GnRH agonist downregulation

This is a randomized controlled trial. Patients will be randomized to two groups during the first consultation. GnRH agonist will be administrated according to the long luteal protocol. Down-regulation of the pituitary will be controlled on the first day of the menstrual period.

The purpose of this study is to compare the pregnancy rates between the two groups. In the eventuality that pituitary down-regulation has not been confirmed (down-regulation levels determined as Ε2<80 pg/ml and progesterone <1.6 ng/ml), the patient will be assigned to a third group (group 3) and ovarian stimulation will only be initiated after down-regulation has been confirmed.

The GnRH agonist that will be administrated is Buserelin Acetate. Recombinant FSH will be used for the ovarian stimulation and dose determination will be based on patient characteristics and previous history.


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   (Adult)
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

Locations
Greece
Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece
Thessaloniki, Greece
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:
Responsible Party: E.M. Kolibianakis, Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00436319     History of Changes
Other Study ID Numbers: UHR-2 
Study First Received: February 16, 2007
Last Updated: February 11, 2016
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
Deslorelin
Triptorelin Pamoate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 23, 2016