Synchronizing Blastocyst in Frozen Embryo Transfer

NCT ID: NCT03128970

Last Updated: 2019-06-27

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

NA

Total Enrollment

742 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-21

Study Completion Date

2018-05-10

Brief Summary

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The aim of the present study is to determine if implantation rate could be increased in women undergoing frozen embryo transfer cycles in case of adjusting their embryo development at hatching stage.

Detailed Description

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Conditions

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Embryo Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers
The gynecologist performing the embryo transfer as well as the patients undergoing frozen embryo transfer will be blinded to group allocation

Study Groups

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frozen/thawed

blastocysts with three or less grade of expansion will be thawed and then subsequently transferred into women uterus three hours post-thawing.

Group Type NO_INTERVENTION

No interventions assigned to this group

synchronized frozen/thawed hatching blastocysts

blastocyst thawing (with three or less grade of expansion) will take place the day before embryo transfer in order to reach hatching stage

Group Type EXPERIMENTAL

synchronizing blastocysts

Intervention Type OTHER

transferring frozen/thawed a synchronized blastocysts at hatching stage into female uterus.

Interventions

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synchronizing blastocysts

transferring frozen/thawed a synchronized blastocysts at hatching stage into female uterus.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients who will agree to participate and assign an informed consent form
2. Only blastocyst transfer FET cycles
3. Patients undergoing FET after their 1st IVF or ICSI cycle with no pregnancy at the fresh transfer
4. Freeze-all cycles due to OHSS
5. Freeze-all cycles due to poor endometrium
6. Age 19-33 at the time of randomization.
7. Their frozen blastocysts are 3 or less grade of expansion.
8. Female with a ≥12 AFCs
9. Endometrial thickness ≥ 8mm at the time of ovulation
10. Women with their male partners will give only fresh semen
11. Women who have no uterine abnormality by ultrasound
12. BMI ≤ 31

Exclusion Criteria

1. Cycles undergoing preimplantation genetic diagnosis.
2. Women who have previous two cycles of implantation failure at fresh transfer
3. Women who have previous two FET failed cycles
4. Any uterine pathology (myomas, adenomyosis, endocrinopathies, thrombophilia, chronic pathologies, acquired or congenital uterine abnormalities)
5. Patients with severe endometriosis
6. Presence of uni- or bilateral hydrosalpinx
7. Recurrent pregnancy loss.
8. Any medical condition that affect fertility.
Minimum Eligible Age

19 Years

Maximum Eligible Age

33 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ganna Fertility Center

OTHER

Sponsor Role collaborator

Al-Yasmeen Fertility and Gynecology Center

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Magdi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Yasmeen fertility and gynecology center

Banhā, , Egypt

Site Status

Ganna Fertility and Gynecology Center

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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001-2017

Identifier Type: -

Identifier Source: org_study_id

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