Duration of GnRH-analogue Downregulation and Pregnancy Rates

Infertility Clinical Trial

Official title:

Effect of the Duration of GnRH-analogue Downregulation on Pregnancy Rates in IVF

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00436319
• Other study ID #: UHR-2
• Status: Terminated
• Phase: Phase 4
• First received: February 16, 2007
• Last updated: February 11, 2016
• Start date: May 2006

Study information

• Verified date: February 2016
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 38 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

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 ?2<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.

Locations

Country	Name	City	State
Greece	Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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. — View 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. Epub 2005 Dec 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rate		2 years	No