Natural Versus Artificial Cycle for Frozen-Thawed Embryo Transfer

NCT ID: NCT03642665

Last Updated: 2025-02-28

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

PHASE4

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-25

Study Completion Date

2024-11-01

Brief Summary

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This study evaluates clinical pregnancy rates, obstetrical outcome parameters, costs and patient preferences in natural cycle versus artificial cycle frozen embryo transfers (FET).

Detailed Description

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Transfer of cryopreserved embryos can be performed in a natural cycle (NC-FET) or in an artificially prepared cycle (AC-FET). Both cycle regimens have their advantages and disadvantages. So far, most comparative studies have failed to identify the optimal protocol for FET. In this study patients undergoing FET will be randomized between an endometrial preparation by a natural cycle or by an artificial cycle (by oestradiol validate and micronized progesterone).

Conditions

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Embryo Transfer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter prospective randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Natural cycle

no medication

Group Type EXPERIMENTAL

Natural cycle

Intervention Type DRUG

no medication

Artificial cycle

Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle. The dose of Progynova is increased to 8mg daily if the endometrial thickness is less than 7mm after 7-10 days of Progynova use. Progynova will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Progynova will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.

Micronized progesterone (Utrogestan, Besins, Belgium) 200 mg vaginally three times daily is started as soon as the endometrial thickness is 7 mm. Utrogestan will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Utrogestan will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.

Group Type ACTIVE_COMPARATOR

Estradiol Valerate

Intervention Type DRUG

Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle. The dose of Progynova is increased to 8mg daily if the endometrial thickness is less than 7mm after 7-10 days of Progynova use. Progynova will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Progynova will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.

Micronized progesterone

Intervention Type DRUG

Micronized progesterone (Utrogestan, Besins, Belgium) 200 mg vaginally three times daily is started as soon as the endometrial thickness is 7 mm. Utrogestan will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Utrogestan will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.

Interventions

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Natural cycle

no medication

Intervention Type DRUG

Estradiol Valerate

Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle. The dose of Progynova is increased to 8mg daily if the endometrial thickness is less than 7mm after 7-10 days of Progynova use. Progynova will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Progynova will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.

Intervention Type DRUG

Micronized progesterone

Micronized progesterone (Utrogestan, Besins, Belgium) 200 mg vaginally three times daily is started as soon as the endometrial thickness is 7 mm. Utrogestan will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Utrogestan will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.

Intervention Type DRUG

Other Intervention Names

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Artificial cycle Artificial cycle

Eligibility Criteria

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Inclusion Criteria

* Women undergoing FET after a first, second or third fresh IVF/ICSI cycle
* Single embryo transfer (SET) or Double embryo transfer (DET)
* Female age between 18-45 year
* Women having a natural ovulatory cycle (24-35 days)
* Normal uterine cavity (fundal indentation at the cavity \<10mm)
* Written informed consent

Exclusion Criteria

* Use of donor gametes
* BMI \> or equal to 35 kg / m2
* Any contra-indication to estrogen or progesterone supplementation (e.g. history of thrombosis, prior or current hormone-sensitive malignancy…)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GZA Ziekenhuizen Campus Sint-Augustinus

OTHER

Sponsor Role collaborator

Imelda Hospital, Bonheiden

OTHER

Sponsor Role collaborator

Jessa Hospital

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S61372

Identifier Type: -

Identifier Source: org_study_id

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