What is the Best Preparation for Embryo Transfer in Cryo Cycles: a Natural Cycle or Light Hormonal Stimulation?

NCT ID: NCT00492934

Last Updated: 2014-09-10

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2014-10-31

Brief Summary

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The study investigates if, among women with a regular cycle (between 25 and 45 days), the endometrium is better prepared for the transfer of an embryo that was cryopreserved and if the subsequent embryo implantation rate is higher when the cycle is started with daily, small-dose hormonal injections than in cycles without these daily injections.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Daily injections with a small dose of gonadotrophins from day 2 of the cycle

Group Type ACTIVE_COMPARATOR

human menopausal gonadotrophins

Intervention Type DRUG

Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation

2

No daily injections with hormones

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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human menopausal gonadotrophins

Daily subcutaneous injections, dose 37.5 IU or 75 IU, start on day 2 of the menstrual cycle until ovulation

Intervention Type DRUG

Other Intervention Names

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Menopur

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent.
* Women with a regular cycle (between 21 and 35 days).
* Embryos with 50% intact blastomeres after thawing.
* Embryo and endometrium are synchronized.

Exclusion Criteria

* Embryo storage time not longer than 5 years.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gasthuisberg

OTHER

Sponsor Role lead

Responsible Party

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Thomas D'Hooghe

Professor, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas D'Hooghe, MD, PhD

Role: STUDY_DIRECTOR

University Hospital Gasthuisberg, Catholic University Leuven, Belgium

Locations

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Leuven University Fertility Center

Leuven, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

References

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Peeraer K, Couck I, Debrock S, De Neubourg D, De Loecker P, Tomassetti C, Laenen A, Welkenhuysen M, Meeuwis L, Pelckmans S, Meuleman C, D'Hooghe T. Frozen-thawed embryo transfer in a natural or mildly hormonally stimulated cycle in women with regular ovulatory cycles: a RCT. Hum Reprod. 2015 Nov;30(11):2552-62. doi: 10.1093/humrep/dev224. Epub 2015 Sep 12.

Reference Type DERIVED
PMID: 26364081 (View on PubMed)

Other Identifiers

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ML2436 - 30/12/2003

Identifier Type: -

Identifier Source: org_study_id

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