Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS

Ovarian Hyperstimulation Syndrome Clinical Trial

Official title:

Coasting Versus Gonadotrophin-Releasing Hormone Antagonist Administration in Patients at High Risk of Ovarian Hyperstimulation Syndrome and Its Impact on the Embryos Quality and the Outcome of ICSI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03996434
• Other study ID #: Clin-I-0201907
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2019
• Est. completion date: November 20, 2019

Study information

• Verified date: November 2019
• Source: ClinAmygate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this work is to study the value of GnRH antagonist subcutaneous administration as an alternative to coasting in prevention of severe OHSS and its impact on embryos quality & the outcome of ICSI.

Description:

Infertility affects up to one in seven couples all over the world. In vitro fertilization-embryo transfer (IVF-ET) and intracytoplasmic sperm injection (ICSI) are commonly used in the management of infertility attributable to tubal factor, significant endometriosis, male factor and also persistent unexplained infertility. Recruitment and development of multiple follicles in response to gonadotrophin stimulation are necessary for successful assisted reproduction. In young ovulating women undergoing IVF treatment, the standard stimulation protocol can result in either poor response or ovarian hyperstimulation syndrome (OHSS).

OHSS is a serious and potentially life-threatening iatrogenic complication of controlled ovarian hyperstimulation (COH) which may cause serious impact on patient's health. OHSS is the most feared complication of IVF-related ovarian stimulation, which in its severe form leads to hospitalization and in the worst case scenario fatal complications. As many as 33% of IVF cycles have been reported to be associated with mild forms of OHSS. The incidence of moderate OHSS is estimated to be between 3% and 6%, while the severe form may occur in 0.1-3% of all cycles. Among high risk women the incidence approaches 20%.

Development of multiple follicles forms the basis of OHSS. Exogenous human chorionic gonadotrophin (hCG) administration for the final maturation of oocytes or endogenous production of hCG after pregnancy is the second factor needed for the development of severe OHSS. Severe OHSS is characterized by massive ovarian enlargement, pleural effusion, ascites, oliguria, hemoconcentration, and thromboembolic phenomena. Coasting is described as a withholding therapy while continuing with releasing hormone agonist/antagonist administration, until safe levels of estradiol (E2) are attained. GnRH antagonists causes an immediate suppression of E2 levels and therefore could prevent OHSS in GnRH antagonist cycles. A comparison between coasting and GnRH antagonist administration in women at high risk of OHSS during ovarian stimulation for IVF with GnRH agonist long protocol, in the hope of preventing the drawbacks of prolonged coasting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 20, 2019
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• infertile women

• age 20-40

• at high risk for OHSS

Exclusion Criteria:

• refuse to participate

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Syndrome

Intervention

Drug:
• Gonadotropin
withholding gonadotropin administration for at least 24 hours
• Antagonist
Cetrorelix acetate 0.25 mg

Locations

Country	Name	City	State
Egypt	Alazahr University	Cairo
Egypt	Assisted Reproduction Unit International Islamic Centre for Population Studies and Research, Al-Azhar University	Cairo

Sponsors (4)

Lead Sponsor	Collaborator
ClinAmygate	Al-Azhar University, Beni-Suef University, Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Aboulghar MA, Mansour RT, Amin YM, Al-Inany HG, Aboulghar MM, Serour GI. A prospective randomized study comparing coasting with GnRH antagonist administration in patients at risk for severe OHSS. Reprod Biomed Online. 2007 Sep;15(3):271-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of high quality embryos	Number of high quality embryos	Within 48 hours of fertilization