Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS

NCT03996434 | Completed Phase 4 DMC

• 1 other identifier: Clin-I-0201907
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Hyperstimulation Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of high quality embryos

  Number of high quality embryos

  Within 48 hours of fertilization

Study Arms (2)

Coasting group

EXPERIMENTAL

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

Antagonist group

ACTIVE COMPARATOR

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

Interventions

Gonadotropin DRUG

withholding gonadotropin administration for at least 24 hours

Coasting group

Antagonist DRUG

Cetrorelix acetate 0.25 mg

Also known as: Cetrorelix acetate

Antagonist group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• refuse to participate

Sponsors & Collaborators

• ClinAmygate: lead
• Cairo University: collaborator
• Al-Azhar University: collaborator
• Beni-Suef University: collaborator

Study Sites (2)

Alazahr University

Cairo, Egypt

Location

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

Cairo, Egypt

Location

Related 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. doi: 10.1016/s1472-6483(10)60339-2.

  PMID: 17854523 RESULT

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Gonadotropins; cetrorelix

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Eman Elgendy, MD

  International Islamic Centre for Population Studies and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 24, 2019
• Study Start: July 1, 2019
• Primary Completion: November 10, 2019
• Study Completion: November 20, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)