Health TrialsbyHealthPanel

Comparison of Two Protocols in Frozen Embryo Transfer

ConditionIVF Outcomes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorMalihe Mahmoudinia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: natural cycle groupNo intervention 0 interventions
Group B: Hormone Replacement Therapy (HRT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical pregnancy rate

presence of gestational sac on ultrasound at 6 weeks

Time frame
6 weeks post-transfer
2

Chemical pregnancy rate

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

Time frame
12-16 days post embryo transfer

Secondary outcomes

1

Ongoing Pregnancy Rate

Pregnancy sustained beyond 20 weeks gestation

Time frame
At 20 weeks after embryo transfer
2

Early Miscarriage Rate

loss of a fetus before 12 weeks of gestation

Time frame
Up to 12 weeks after embryo transfer
3

Late Miscarriage Rate

loss of a fetus after 12 weeks and before 24 weeks

Time frame
up to 24 weeks gestation
4

Live Birth Rate

Birth of at least one live neonate after 24 completed weeks of gestation

Time frame
At delivery, After 24 weeks gestation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Malihe Mahmoudinia

Lead sponsor

Mashhad University of Medical Sciences

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: