Impact of Endometrial Compaction on Clinical Pregnancy Rate in Frozen Embryo Transfers

NCT06583265 | Unknown

• 1 other identifier: Endometrial Compaction
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To find out if the percentage of endometrial compaction is correlated to clinical pregnancy rate in down regulated frozen embryo transfer cycle. Endometrial compaction is the change in endometrial thickness between the end of the estrogen only phase and the day of embryo transfer. In concept, the compaction of the endometrium after progesterone initiation indicates that the endometrium is responsive to progesterone and could therefore be used as a proxy for endometrial receptivity predictability of FET cycle outcome

Conditions

IVF

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  Clinical pregnancy rate, determined by visualizing a viable embryo within the uterine cavity by ultrasound 3-4 weeks after ET, in patients with endometrial compaction in down regulated FET cycles in comparison to non endometrial compaction.

  3-4 wks after ET

Secondary Outcomes (3)

• Percentage of change of endometrial thickness between the end of estrogen administration only phase and the day of embryo transfer.

  3-4 wks after ET

• Chemical pregnancy rates, detected by positive hCG test in the absence of pregnancy findings on TVUS

  3-4 wks after ET

• Number of estrogen administration days

  10 days before ET

Study Arms (1)

Infertility patients planning for FET

Drug: Observational

Interventions

Observational DRUG

To observe if endometrial compaction ≥ 5% in down regulated FET cycles increases clinical pregnancy rate.

Infertility patients planning for FET

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infertility patients planning for FET

You may qualify if:

• Women undergoing down regulated cycles frozen embryo transfer.
• Women at age group 20-35 years old.
• Day 5 embryos will be transferred.

You may not qualify if:

• Chromosomal abnormality in either partner (As this could lead to cycle cancellation).
• Uterine malformation or any intrauterine condition affecting the pregnancy outcomes of FET, such as endometrial polyps, uterine cavity adhesion, history of endometrial tuberculosis, hydrosalpinx with a reflux into uterine cavity (As the might not be candidates for IVF cycle till correction).
• Recurrent implantation failure, defined as 2 or more previous failed trials (Other confounding factors might of present which could affect the results).
• Cycles of patients with persistent endometrial thickness \<7mm during treatment protocol (Due to cycled cancelation).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 4, 2024
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-01

Locations

EG (1)