Clinical trial NCT00436319: Duration of GnRH-analogue Downregulation and Pregnancy Rates
Official title: Effect of the Duration of GnRH-analogue Downregulation on Pregnancy Rates in IVF
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infertility
Keywords: Infertility, downregulation, stimulation, agonists, long
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2007-02-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: pregnancy rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece
Study officials:
affiliation: Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece
name: Basil C Tarlatzis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Damario MA, Moomjy M, Tortoriello D, Moy F, Davis OK, Rosenwaks Z. Delay of gonadotropin stimulation in patients receiving gonadotropin-releasing hormone agonist (GnRH-a) therapy permits increased clinic efficiency and may enhance in vitro fertilization (IVF) pregnancy rates. Fertil Steril. 1997 Dec;68(6):1004-10. doi: 10.1016/s0015-0282(97)00392-0.
citation: Kolibianakis EM, Papanikolaou EG, Camus M, Tournaye H, Van Steirteghem AC, Devroey P. Menstruation-free interval and ongoing pregnancy in IVF using GnRH antagonists. Hum Reprod. 2006 Apr;21(4):1012-7. doi: 10.1093/humrep/dei415. Epub 2005 Dec 8.