Current partner codePEPTIDESDE
NCT03996434·Phase 4·INTERVENTIONAL

Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS

Status

Completed

Phase

Phase 4

Enrollment

300

Locations

2

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Gonadotropin

withholding gonadotropin administration for at least 24 hours

DRUG

Antagonist

Cetrorelix acetate 0.25 mg

Timeline

From registration to results.

  1. First posted

    Jun 24, 2019

  2. Study start

    Jul 1, 2019

  3. Primary completion

    Nov 10, 2019

  4. Study completion

    Nov 20, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Nov 21, 2019

Outcomes

What the study measures.

Primary outcomes

Number of high quality embryos

Time frame · Within 48 hours of fertilization

Number of high quality embryos

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * infertile women * age 20-40 * at high risk for OHSS Exclusion Criteria: * refuse to participate

Study locations

2 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Alazahr University

Cairo, Egypt

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

Cairo, Egypt

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

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