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Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Gonadotropin
Antagonist
Sponsored by
ClinAmygate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • infertile women
  • age 20-40
  • at high risk for OHSS

Exclusion Criteria:

  • refuse to participate

Sites / Locations

  • Alazahr University
  • Assisted Reproduction Unit International Islamic Centre for Population Studies and Research, Al-Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coasting group

Antagonist group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of high quality embryos
Number of high quality embryos

Secondary Outcome Measures

Full Information

First Posted
June 21, 2019
Last Updated
November 20, 2019
Sponsor
ClinAmygate
Collaborators
Cairo University, Al-Azhar University, Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT03996434
Brief Title
Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ClinAmygate
Collaborators
Cairo University, Al-Azhar University, Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coasting group
Arm Type
Experimental
Arm Description
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.
Arm Title
Antagonist group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gonadotropin
Intervention Description
withholding gonadotropin administration for at least 24 hours
Intervention Type
Drug
Intervention Name(s)
Antagonist
Other Intervention Name(s)
Cetrorelix acetate
Intervention Description
Cetrorelix acetate 0.25 mg
Primary Outcome Measure Information:
Title
Number of high quality embryos
Description
Number of high quality embryos
Time Frame
Within 48 hours of fertilization

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infertile women age 20-40 at high risk for OHSS Exclusion Criteria: refuse to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Elgendy, MD
Organizational Affiliation
International Islamic Centre for Population Studies and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alazahr University
City
Cairo
Country
Egypt
Facility Name
Assisted Reproduction Unit International Islamic Centre for Population Studies and Research, Al-Azhar University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Local regulations
Citations:
PubMed Identifier
17854523
Citation
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. doi: 10.1016/s1472-6483(10)60339-2.
Results Reference
result

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Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS

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