About this trial
This study will assess the convenience of the natural proliferative phase frozen embryo transfer (NPP-FET) in terms of number of number of appointments needed before cycle scheduling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Endometrial thickness ≥ 7 mm on the day of starting progesterone-based luteal phase support (LPS)
Serum progesterone levels <1.5 ng/ml on the day of starting progesterone-based LPS
LPS with micronized progesterone 400mg b.i.d.
Regular cycles (>24 days, ≤ 38 days)
Disqualifiers
Use of exogenous ovarian stimulation during FET
Untreated hydrosalpinx, polyp, submucous myomas or severe adenomyosis
Recurrent pregnancy loss (≥ 3 previous pregnancy losses)
Recurrent implantation failure with embryos from oocyte donation (≥ 3 previous failed embryo transfers)
Trial population
The study group will include a prospectively recruited cohort of ovulatory patients undergoing their first or second FET attempt following oocyte donation in a natural proliferative phase protocol. The control group will include a retrospective cohort of ovulatory patients undergoing a natural cycle frozen embryo transfer following oocyte donation.
Trial design
Cohort
Other
Treatments tested in this trial
Natural proliferative phase frozen embryo transfer
Procedure/SurgeryWhen endometrial thickness is above 7 mm, vaginal micronized progesterone will be administered 400mg 12/12h when the dominant follicle is at least 13 mm, serum estradiol (E2) levels are \>80 pg/ml, and serum progesterone levels are \<1.5ng/ml. Embryo transfer will be performed on the fifth day of progesterone.
Treatment groups
Trial outcomes
Primary outcomes
Number of appointments needed before cycle scheduling
Number of visits for cycle monitoring until embryo transfer scheduling
Secondary outcomes
Cycle duration until embryo transfer (days)
Number of days since the first day of menstrual bleeding until the day of embryo transfer
Proportion of patients with low progesterone values on the day of embryo transfer
Percentage of patients with low serum progesterone levels on the day of embryo transfer
Human corionic gonadotropin (hCG) positive rate
Proportion of patients with a positive hCG test
Miscarriage rate
Proportion of patients with spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age
Other outcomes
Serum Relaxin-2 levels
Serum Relaxin-2 levels (colateral study)
Serum Luteinizing Hormone (LH) levels
Serum LH levels (colateral study)
Sponsors and contacts
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Instituto Valenciano de Infertilidade de Lisboa
Lead sponsor
Gedeon Richter Ltd.
Collaborator