Natural Versus Artificial Cycle for Frozen-Thawed Embryo Transfer (NAFT)

February 19, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

Frozen-thawed Embryo Transfer in a Natural Versus Artificial Cycle: a Randomized Clinical Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

554

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Natural cycle
no medication
Drug: Natural cycle
no medication
Active Comparator: 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.
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.
Other Names:
  • Artificial cycle
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.
Other Names:
  • Artificial cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate with fetal heart beat
Time Frame: 9 weeks
Clinical pregnancy rate with fetal heart beat diagnosed by ultrasound no later than the gestational age of 9 weeks
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical pregnancy rate
Time Frame: 9 weeks
9 weeks
Miscarriage rate
Time Frame: 12 weeks
12 weeks
Ectopic pregnancy rate
Time Frame: 9 weeks
9 weeks
Live birth rate
Time Frame: 41 weeks
41 weeks
Multiple pregnancy rate
Time Frame: 9 weeks
9 weeks
Adverse events
Time Frame: 12 weeks
tombo-embolic events, serious side-effects (car leaflet) which require cancellation of treatment
12 weeks
Cycle cancellation rate
Time Frame: 4 weeks
4 weeks
Endometrial thickness
Time Frame: 3 weeks
3 weeks
Endometrial pattern
Time Frame: 3 weeks
Sonographic aspect of the endometrium (triple-line, no triple-line)
3 weeks
number of center visits to monitor FET cycle
Time Frame: From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks)
From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks)
cost analysis per treatment cycle
Time Frame: From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks)
From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks)
patient satisfaction
Time Frame: 12 weeks
To evaluate the effect of the different regimens on patients wellbeing/distress, Patient Reported Experience Measures (PREMS) from validated questionnaires will be used. Twenty-two questions from the Benyamini questionnaire will be used (Benyamini et al. 2005) and 10 questions from the subscales 'environment' (α=0.81) and 'tolerability' (α=0.75) of the FertilQol questionnaire (Pedro et al 2013). On the day of embryo transfer, the treating gynecologist will hand out the questionnaire to the patient. The patient will return the filled-in questionnaire on the day of the pregnancy test, before she knows the result of the pregnancy test.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Jessa Hospital
Imelda Hospital, Bonheiden
GZA Ziekenhuizen Campus Sint-Augustinus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2018

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S61372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Embryo Transfer

Clinical Trials on Natural cycle

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe