Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos

• Conditions: Infertility, Female
• Interventions: Other: natural cycle; Other: modified natural cycle; Other: embryo transfer

• Registration Number: NCT03798886
• Lead Sponsor: Acibadem University

Brief Summary

There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer

Detailed Description

There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer, with reports from observational studies and randomized controlled trials suggesting that:

1. The endometrium in stimulated cycles is not optimal for implantation

2. Pregnancy rates are increased following FET

3. Perinatal outcomes are less affected after FET

4. Preimplantation genetic screening We will follow only natural and modified natural cycles patients. Spontaneous ovulation will documented with hormonal and sonographic monitoring. Hormonal monitoring are including estradiol and luteinizing hormone (LH). Sonographic monitoring is including follicule diameter (16-20 mm). At modified natural cycles we will use hCG triggering for ovulation approximately 16-20 mm diameter.

We will compare success rate between natural and modified natural cycles

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Patient who are admitted to the IVF center and who will be transferred to frozen embryos.
• Infertile women under 40 years of age who accepted this study.
• Unexplained infertilite couple.
• All ovulatory patient.
• Male factor.
• Tubal factor.

Exclusion Criteria

• Patients who made intrauterin surgery.
• Over 40 years of age women.
• Patients with preimplantation genetic diagnosis.
• Anovulatory patient.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Natural frozen embryo transfer group	natural cycle	In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. After spontaneous ovulation, embryo transfer will be planned. Luteal phase support will not be used.
modified natural embryo transfer group	natural cycle	In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. When follicle diameter is 16-17 mm we will apply hCG (recombinant hCG). After ovulation, embryo transfer will be done. Luteal phase support will not be used.
Natural frozen embryo transfer group	modified natural cycle	In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. After spontaneous ovulation, embryo transfer will be planned. Luteal phase support will not be used.
Natural frozen embryo transfer group	embryo transfer	In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. After spontaneous ovulation, embryo transfer will be planned. Luteal phase support will not be used.
modified natural embryo transfer group	modified natural cycle	In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. When follicle diameter is 16-17 mm we will apply hCG (recombinant hCG). After ovulation, embryo transfer will be done. Luteal phase support will not be used.
modified natural embryo transfer group	embryo transfer	In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. When follicle diameter is 16-17 mm we will apply hCG (recombinant hCG). After ovulation, embryo transfer will be done. Luteal phase support will not be used.

Primary Outcome Measures

Name	Time	Method
birth	bigger than 24 weeks pregnancy	live birth

Secondary Outcome Measures

Name	Time	Method
pregnancy rate	10th day after embryo transfer	hcg blood test
abortion rate	8 weeks	abortion after visualization of fetal cardiac activity
clinical pregnancy rate	8 weeks	positive fetal cardiac activity

Trial Locations

Locations (1)

Acibadem MAA University Atakent Hospital; 🇹🇷 Istanbul, Turkey