Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS

• Sponsor: ClinAmygate (Other)
• Overall Status: Completed
• CT.gov ID: NCT03996434
• Collaborator: Cairo University (Other), Al-Azhar University (Other), Beni-Suef University (Other)
• Enrollment: 300
• Locations: 2
• Arms: 2
• Actual Duration (Months): 4.7
• Patients Per Site: 150
• Patients Per Site Per Month: 32.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Hyperstimulation Syndrome	Drug: Gonadotropin; Drug: Antagonist	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Nov 10, 2019
• Actual Study Completion Date: Nov 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coasting group Including 150 patients who will undergo withholding gonadotropin administration for at least 24 hours before triggering ovulation with hCG. GnRH agonist will be continued daily till the day of triggering. E2 will be measured daily until the concentration falls to ≤ 3000 pg/ml, then 5000 IU of hCG will be given.	Drug: Gonadotropin; withholding gonadotropin administration for at least 24 hours
Active Comparator: Antagonist group Including 150 patients who will receive GnRH antagonist (subcutaneous injection Cetrorelix acetate 0.25 mg (Cetrotide, Serono, UK)) daily until the day of hCG administration. GnRH agonist will be discontinued at the start of antagonist administration. E2 will be measured daily until the concentration falls to ≤ 3000 pg/ml and TVS revealed that follicles diameter is ≥ 18 mm, then 5000 IU of hCG will be given.	Drug: Antagonist; Cetrorelix acetate 0.25 mg; Other Names: Cetrorelix acetate

Outcome Measures

Primary Outcome Measures

1. Number of high quality embryos [Within 48 hours of fertilization]

   Number of high quality embryos

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• infertile women

• age 20-40

• at high risk for OHSS

Exclusion Criteria:

• refuse to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alazahr University	Cairo		Egypt
2	Assisted Reproduction Unit International Islamic Centre for Population Studies and Research, Al-Azhar University	Cairo		Egypt

Sponsors and Collaborators

• ClinAmygate
• Cairo University
• Al-Azhar University
• Beni-Suef University

Investigators

• Principal Investigator: Eman Elgendy, MD, International Islamic Centre for Population Studies and Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ClinAmygate
• ClinicalTrials.gov Identifier: NCT03996434
• Other Study ID Numbers: Clin-I-0201907
• First Posted: Jun 24, 2019
• Last Update Posted: Nov 21, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome; Cetrorelix

Study Results

No Results Posted as of Nov 21, 2019