Synchronizing Blastocyst in Frozen Embryo Transfer

Embryo Implantation Clinical Trial

Official title:

Synchronizing Blastocyst at Hatching Stage in Frozen Embryo Transfer Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128970
• Other study ID #: 001-2017
• Status: Completed
• Phase: N/A
• Start date: April 21, 2017
• Est. completion date: May 10, 2018

Study information

• Verified date: June 2019
• Source: Al-Yasmeen Fertility and Gynecology Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: May 10, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 33 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embryo Implantation

Intervention

Other:
• synchronizing blastocysts
transferring frozen/thawed a synchronized blastocysts at hatching stage into female uterus.

Locations

Country	Name	City	State
Egypt	Al-Yasmeen fertility and gynecology center	Banha
Egypt	Ganna Fertility and Gynecology Center	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Al-Yasmeen Fertility and Gynecology Center	Ganna Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing implantation rate	ultrasound detection of ongoing gestational sacs with heartbeats after 12 weeks of gestation per transferred embryos	12 weeks