Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?

NCT ID: NCT02044445

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is administered to trigger the final follicular maturation before oocyte retrieval, in an attempt to mimic the physiologic effects of LH. The hCG is administered when more than three follicles ≥17mm in mean diameter have developed.

The time interval between hCG administration and oocyte retrieval is of critical importance since the time after luteinizing stimulus is a period of intense processes including the start of luteinization, expansion of cumulus cells and oocyte meiotic maturation.

The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown that significantly more high quality embryos have been obtained with a prolonged hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be beneficial in improving oocyte quality and achieving optimal maturation.

Currently there are no data on the effect of the time interval between hCG administration and oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to determine whether there is any difference in in vitro fertilization outcome when oocyte retrieval takes place at 36 h or 38 h following hCG administration

Detailed Description

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Conditions

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Subfertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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36 h group

Oocyte retrieval will be performed 36 hours after hCG administration

Group Type ACTIVE_COMPARATOR

Oocyte retrieval will be performed 36 h or 38 h after hCG administration

Intervention Type PROCEDURE

Oocyte retrieval will be performed 36 h or 38 h after hCG administration

38 h group

Oocyte retrieval will be performed 38 hours after hCG administration

Group Type ACTIVE_COMPARATOR

Oocyte retrieval will be performed 36 h or 38 h after hCG administration

Intervention Type PROCEDURE

Oocyte retrieval will be performed 36 h or 38 h after hCG administration

Interventions

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Oocyte retrieval will be performed 36 h or 38 h after hCG administration

Oocyte retrieval will be performed 36 h or 38 h after hCG administration

Intervention Type PROCEDURE

Other Intervention Names

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oocyte retrieval at 36 hours following hCG administration oocyte retrieval at 38 hours following hCG administration

Eligibility Criteria

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Inclusion Criteria

* women undergoing fresh IVF cycle with recombinant FSH and GnRH antagonists
* regular spontaneous menstrual cycle (24-35 days)
* age ≤ 43 years
* FSH ≤ 20 IU/L

Exclusion Criteria

* History of previous ovarian surgery
* Women with Stage III-IV Endometriosis
* Women undergoing natural cycle IVF
Minimum Eligible Age

20 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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E.M. Kolibianakis

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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UHR-10

Identifier Type: -

Identifier Source: org_study_id

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