Natural Versus Artificial Cycle for Frozen-Thawed Embryo Transfer

Embryo Transfer Clinical Trial

— NAFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03642665
• Other study ID #: S61372
• Status: Recruiting
• Phase: Phase 4
• Start date: September 25, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 554
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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…)

Related Conditions & MeSH terms

• Embryo Transfer

Intervention

Drug:
• Natural cycle
no medication
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (4)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	GZA Ziekenhuizen Campus Sint-Augustinus, Imelda Hospital, Bonheiden, Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate with fetal heart beat	Clinical pregnancy rate with fetal heart beat diagnosed by ultrasound no later than the gestational age of 9 weeks	9 weeks
Secondary	Biochemical pregnancy rate		9 weeks
Secondary	Miscarriage rate		12 weeks
Secondary	Ectopic pregnancy rate		9 weeks
Secondary	Live birth rate		41 weeks
Secondary	Multiple pregnancy rate		9 weeks
Secondary	Adverse events	tombo-embolic events, serious side-effects (car leaflet) which require cancellation of treatment	12 weeks
Secondary	Cycle cancellation rate		4 weeks
Secondary	Endometrial thickness		3 weeks
Secondary	Endometrial pattern	Sonographic aspect of the endometrium (triple-line, no triple-line)	3 weeks
Secondary	number of center visits to monitor FET cycle		From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks)
Secondary	cost analysis per treatment cycle		From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks)
Secondary	patient satisfaction	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' (a=0.81) and 'tolerability' (a=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