Health TrialsbyHealthPanel

Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support

ConditionsPregnancy RelatedInfertility, Female
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorART Fertility Clinics LLC

About this trial

To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18 to 40 years

Regular ovulatory cycles

Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6

Detection of ovulation by P4 rise > 1.0 ng/ml after LH surge

Disqualifiers

History of repeated pre-menstrual spotting

Factors affecting the implantation through anatomical changes of the uterus / ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids / polyps, isthmocele with intracavitary fluid presence, hydrosalpinx….)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transvaginal ultrasound

    Diagnostic test

    Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth

  • Serial serum LH, E2, P4

    Diagnostic test

    Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017).

  • Progesterone 100 Mg Vaginal Insert

    Drug

    On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy

  • Serum P4 day of ET - Control Group

    Diagnostic test

    Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure

  • Serum P4 day of ET - Study Group

    Diagnostic test

    Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.

  • Embryo transfer

    Procedure/Surgery

    The procedure in which embryo is placed in the uterus.

  • Serum hCG 10 days after ET

    Diagnostic test

    Pregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of \> 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)

  • Serum P4 10 days after ET

    Diagnostic test

    Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure

Treatment groups

342 Participants
are divided into 2 treatment groups
Group A: Study GroupOther 6 interventions
Group B: Control GroupOther 7 interventions

Trial outcomes

Primary outcomes

1

Implantation rate

Number of embryos which have produced ultrasonographic evidence of an intrauterine gestational sac per the total number of embryos transferred into the uterine cavity (Zegers-Hochschild et al., 2009).

Time frame
2 months
2

Clinical pregnancy rate

hCG \> 15 Iu/ml and ultrasound confirmation of a gestational sac

Time frame
2 months
3

Live birth rate

Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)

Time frame
41 weeks
4

Serum P4 levels on ET day

Progesterone level on the day of embryo transfer

Time frame
1 day

Secondary outcomes

Other outcomes

Sponsors and contacts

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

ART Fertility Clinics LLC

Lead sponsor

Source ClinicalTrials.gov
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