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Progesterone-modified Natural Cycle for FET

ConditionInfertility, Female
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age21-44
SponsorShandong University of Traditional Chinese Medicine

About this trial

Hormone replacement therapy (HRT) cycles, despite the ease of synchronizing embryo thawing and embryo transfer timing, increase the risk of pregnancies and obstetric complications compared to natural cycles (NC). By ensuring the presence of the corpus luteum while reducing the number of monitoring sessions, the progesterone modified natural cycle (P4mNC) offers more convenience for the patient than the normal NC. This study is designed to compare the effects of P4mNC and HRT cycles on FET outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 21 to 44 years undergoing FBT

Body mass index (BMI) 18-35 kg/m2

Having regular ovulatory cycles

Disqualifiers

Untreated uterine adhesions

Medical contraindications to estrogen and progesterone therapy

Illnesses contraindicating assisted reproductive technology or pregnancy

History of recurrent implantation failures (> 2 embryo transfer failures)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Progesterone-modified natural cycle preparation for frozen embryo transfer

    Drug

    A novel endometrial preparation protocol that optimizes the natural cycle, whereby as long as the thickness of the endometrium is suitable for embryo transfer, vaginal progesterone can be used to transform the endometrium before ovulation and subsequently FET.

  • Hormone replacement therapy cycle preparation for frozen embryo transfer

    Drug

    A traditional endometrial preparation protocol is used for FET, which involves using fixed or flexible exogenous estradiol for artificial cycles. This protocol typically involves starting exogenous estradiol on day 3 or 4 of the cycle, continuing for 7-10 days, and then discontinuing. Upon determining that the endometrial thickness meets the standard, progesterone conversion of the endometrium can be performed.

Treatment groups

336 Participants
are divided into 2 treatment groups
Group A: P4mNC groupExperimental treatment 1 intervention
Group B: HRT groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Live birth

A live birth is defined as the delivery of any surviving newborn at 28 weeks or more of gestation.

Time frame
Within 1 year after randomization

Secondary outcomes

1

Biochemical pregnancy

Serum level of ß-hCG \> 50 mIU/mL

Time frame
Two weeks after embryo transfer
2

Clinical pregnancy

Fetal heartbeat observed by vaginal ultrasound

Time frame
Five weeks after embryo transfer
3

Ongoing pregnancy

The presence of a gestational sac and fetal heartbeat after 12 weeks of gestation

Time frame
Ten weeks after embryo transfer
4

Miscarriage

A condition in which the embryo or fetus does not survive and is not spontaneously absorbed or expelled from the uterus

Time frame
Within 28 weeks of pregnancy

Other outcomes

Sponsors and contacts

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

Shandong University of Traditional Chinese Medicine

Lead sponsor

Source ClinicalTrials.gov
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