Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos

March 12, 2019 updated by: Acibadem University

Comparison of Clinical Results of Frozen Embryo Transfer in Natural and Modified Natural Cycles

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

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

  • Turkey
      • Istanbul, Turkey, 34457
        • Acibadem MAA University Atakent Hospital

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 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

This study will bw carried out as a prospective randomized clinical trial on regular menstruating patients arriving for transfer of frozen embryo to the center in a single IVF center. Results will collected and recorded daily during the study. With 80% power analysis minimum number of patients 0.05% significance level is 240.

Study will be designed in 1 year.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Natural frozen embryo transfer group
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.
Other: natural cycle
When follicle is ready for ovulation, we will use this injection by intra-dermal route
Other Names:
  • natural LH surge
Other: modified natural cycle
we will use that drug in the natural modified transfer group after embryo transfer
Other Names:
  • recombinant hcg
Other: embryo transfer
we will do transfer when the endometrium is ready
Other Names:
  • frozen embryo transfer
modified natural embryo transfer group
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.
Other: natural cycle
When follicle is ready for ovulation, we will use this injection by intra-dermal route
Other Names:
  • natural LH surge
Other: modified natural cycle
we will use that drug in the natural modified transfer group after embryo transfer
Other Names:
  • recombinant hcg
Other: embryo transfer
we will do transfer when the endometrium is ready
Other Names:
  • frozen embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
birth
Time Frame: bigger than 24 weeks pregnancy
live birth
bigger than 24 weeks pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: 10th day after embryo transfer
hcg blood test
10th day after embryo transfer
clinical pregnancy rate
Time Frame: 8 weeks
positive fetal cardiac activity
8 weeks
abortion rate
Time Frame: 8 weeks
abortion after visualization of fetal cardiac activity
8 weeks

Collaborators and Investigators

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

Sponsor

Acibadem University

Investigators

  • Study Director: Turgut Aydın, Acıbadem University Atakent Hospital
  • Study Chair: Elif Ganime Aydeniz, Acıbadem University Atakent Hospital
  • Study Chair: Emine Karabük, Acıbadem University Atakent Hospital
  • Study Chair: Burak Yücel, Kanuni Sultan SüleymanHospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 8, 2019

First Posted (ACTUAL)

January 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2018/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We did not decide for this but if they need any information we can support all

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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