Duration of GnRH-analogue Downregulation and Pregnancy Rates
|ClinicalTrials.gov Identifier: NCT00436319|
Recruitment Status : Terminated
First Posted : February 19, 2007
Last Update Posted : February 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Procedure: Duration of GnRH agonist downregulation||Phase 4|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- pregnancy rate [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436319
|Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece|
|Principal Investigator:||Basil C Tarlatzis, MD PhD||Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece|