An interventional study of hormone replacement therapy (HRT) group in IVF Outcomes, sponsored by Malihe Mahmoudinia. Not yet recruiting. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Malihe Mahmoudinia · Not applicable, Interventional, and Treatment
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.
This prospective, randomized controlled clinical trial is conducted on women aged 18 to 42 years undergoing frozen embryo transfer (FET) during in vitro fertilization (IVF) cycles. Eligible participants meet the inclusion criteria and provide written informed consent.
Participants are randomized into two groups using a permuted block method:
HRT Group (Control): 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.
Natural Cycle Group: 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.
Embryos are cultured in Blastocyst medium (Origio, Denmark) and assessed daily. High-quality embryos (Grade A) are defined by a 4-cell stage on day 2, a 7-8 cell stage on day 3, uniform cell size, and \<20% fragmentation. Blastocyst grading follows Gardner's criteria. One or two top-quality embryos are transferred using a Cook catheter under abdominal ultrasound guidance. If no blastocyst is available by day 5, the most advanced embryo is transferred.
Malihe Mahmoudinia is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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
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
Drug: hormone replacement therapy (HRT) group
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.
Clinical pregnancy rate
presence of gestational sac on ultrasound at 6 weeks
Time frame: 6 weeks post-transfer
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
Ongoing Pregnancy Rate
Pregnancy sustained beyond 20 weeks gestation
Time frame: At 20 weeks after embryo transfer
Early Miscarriage Rate
loss of a fetus before 12 weeks of gestation
Time frame: Up to 12 weeks after embryo transfer
Late Miscarriage Rate
loss of a fetus after 12 weeks and before 24 weeks
Time frame: up to 24 weeks gestation
Live Birth Rate
Birth of at least one live neonate after 24 completed weeks of gestation
Time frame: At delivery, After 24 weeks gestation
Cycle Cancellation Rate
Proportion of treatment cycles canceled before embryo transfer
Time frame: Up to the day of embryo transfer
Pregnancy Complications
Incidence of pregnancy-related complications, including: Preeclampsia: Onset of hypertension after 20 weeks of gestation, Gestational Diabetes, Placental Abruption,Placenta Previa
Time frame: through study completion, an average of 1 year
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Malihe Mahmoudinia