Synchronizing Blastocyst in Frozen Embryo Transfer

NCT03128970 | Completed DMC

• 1 other identifier: 001-2017
• Study Type: interventional
• Target: 742
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Embryo Implantation

Outcome Measures

Primary Outcomes (1)

• Ongoing implantation rate

  ultrasound detection of ongoing gestational sacs with heartbeats after 12 weeks of gestation per transferred embryos

  12 weeks

Study Arms (2)

frozen/thawed

NO INTERVENTION

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

synchronized frozen/thawed hatching blastocysts

EXPERIMENTAL

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

Other: synchronizing blastocysts

Interventions

synchronizing blastocysts OTHER

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

synchronized frozen/thawed hatching blastocysts

Eligibility Criteria

• Age: 19 Years - 33 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Yasmeen Fertility and Gynecology Center: lead
• Ganna Fertility Center: collaborator

Study Sites (2)

Al-Yasmeen fertility and gynecology center

Banhā, Egypt

Location

Ganna Fertility and Gynecology Center

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The gynecologist performing the embryo transfer as well as the patients undergoing frozen embryo transfer will be blinded to group allocation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 25, 2017
• Study Start: April 21, 2017
• Primary Completion: January 15, 2018
• Study Completion: May 10, 2018
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

EG (2)