Comparison of Two Protocols in Frozen Embryo Transfer

NCT07003373 | Not Yet Recruiting

• 1 other identifier: IR.MUMS.IRH.REC.1403.221
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized clinical trial evaluates two different endometrial preparation protocols-hormone replacement therapy (HRT) and natural cycle-for frozen embryo transfer (FET) in infertile women undergoing assisted reproductive technology (ART). The goal is to compare implantation, clinical pregnancy, and ongoing pregnancy outcomes.

Conditions

IVF Outcomes

Keywords

Natural cycle; Artificial cycle; Frozen embryo transfer

Outcome Measures

Primary Outcomes (2)

• Clinical pregnancy rate

  presence of gestational sac on ultrasound at 6 weeks

  6 weeks post-transfer

• Chemical pregnancy rate

  Positive BHCG test greater than 25 mIU/ml after 12-16 days of embryo transfer

  12-16 days post embryo transfer

Secondary Outcomes (6)

• Ongoing Pregnancy Rate

  At 20 weeks after embryo transfer

• Early Miscarriage Rate

  Up to 12 weeks after embryo transfer

• Late Miscarriage Rate

  up to 24 weeks gestation

• Live Birth Rate

  At delivery, After 24 weeks gestation

• Cycle Cancellation Rate

  Up to the day of embryo transfer

Study Arms (2)

natural cycle group

NO INTERVENTION

A transvaginal ultrasound is performed on cycle day 2 or 3 to rule out ovarian cysts and confirm an endometrial thickness \<5 mm. If eligible, patients are monitored from day 8 onward. Ovulation is tracked by assessing dominant follicle growth (≥15 mm), LH surge (≥17 IU/L), and serum progesterone (\>1.5 ng/mL). Once ovulation is confirmed and endometrial thickness reaches ≥7 mm, FET is scheduled for 6 days post-LH surge or 5 days post-follicle collapse. Serum progesterone is measured one day before transfer; if \<10 ng/mL, 400 mg/day progesterone is administered

Hormone Replacement Therapy (HRT)

EXPERIMENTAL

Drug: hormone replacement therapy (HRT) group

Interventions

hormone replacement therapy (HRT) group DRUG

Estradiol valerate is initiated at 4 mg/day on day 2 of the menstrual cycle and is adjusted to 8 mg/day based on endometrial thickness. Once the endometrial thickness reaches ≥8 mm, progesterone supplementation is started (400 mg vaginal suppositories twice daily and 50 mg intramuscular injections daily) for 5 days before blastocyst transfer.

Hormone Replacement Therapy (HRT)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Regular menstrual cycles
• Maternal age between 18 and 42 years
• Normal intrauterine cavity confirmed by pretreatment ultrasound or hysteroscopy
• Body Mass Index (BMI) less than 30 kg/m²
• No ovulation disorders

You may not qualify if:

• No embryos available for transfer (no embryo thawing)
• Withdrawal of patient consent to continue treatment
• Failure of dominant follicle development (in natural cycle group)
• Inadequate endometrial response for transfer
• No endometriosis grade 3 or higher
• The participant provided written informed consent

Sponsors & Collaborators

• Malihe Mahmoudinia: lead

MeSH Terms

Interventions

Hormone Replacement Therapy; Population Groups

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Demography; Population Characteristics

Central Study Contacts

Malihe Mahmoudinia, Prof

CONTACT

09153047813; mahmoudiniam@mums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of obstetrics & Gynecology, Fellowship of infertility, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: June 4, 2025
• Study Start: July 5, 2025
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): July 5, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05