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Duration of GnRH-analogue Downregulation and Pregnancy Rates

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ClinicalTrials.gov Identifier: NCT00436319
Recruitment Status : Terminated
First Posted : February 19, 2007
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
E.M. Kolibianakis, Aristotle University Of Thessaloniki

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Procedure: Duration of GnRH agonist downregulation Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of the Duration of GnRH-analogue Downregulation on Pregnancy Rates in IVF
Study Start Date : May 2006
Actual Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Deslorelin
U.S. FDA Resources

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: 2 years ]


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Ages Eligible for Study:   19 Years to 38 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: E.M. Kolibianakis, Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00436319     History of Changes
Other Study ID Numbers: UHR-2
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

Keywords provided by E.M. Kolibianakis, 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