Assessing the Convenience of Natural Proliferative Phase Frozen Embryo Transfer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-49
SponsorInstituto Valenciano de Infertilidade de Lisboa

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Natural proliferative phase frozen embryo transfer

    Procedure/Surgery

    When 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

530 Participants
are divided into 2 treatment groups
Group A: Natural proliferative phase frozen embryo transfer (NPP-FET)1 intervention
Group B: Natural cycle frozen embryo transfer (NC-FET)0 interventions

Trial outcomes

Primary outcomes

1

Number of appointments needed before cycle scheduling

Number of visits for cycle monitoring until embryo transfer scheduling

Time frame
Up to three weeks

Secondary outcomes

1

Cycle duration until embryo transfer (days)

Number of days since the first day of menstrual bleeding until the day of embryo transfer

Time frame
Up to four weeks
2

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

Time frame
One day
3

Human corionic gonadotropin (hCG) positive rate

Proportion of patients with a positive hCG test

Time frame
10-14 days after ET
4

Miscarriage rate

Proportion of patients with spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age

Time frame
Up to 20 weeks after ET

Other outcomes

1

Serum Relaxin-2 levels

Serum Relaxin-2 levels (colateral study)

Time frame
5 weeks
2

Serum Luteinizing Hormone (LH) levels

Serum LH levels (colateral study)

Time frame
5 days

Sponsors and contacts

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