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Luteal Support in Frozen-Thawed Embryo Transfer Cycles

Which Luteal Support in Frozen-Thawed Embryo Transfer Cycles: A Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03948022
Enrollment
151
Registered
2019-05-13
Start date
2021-06-30
Completion date
2021-12-20
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assisted Reproduction, Frozen Embryo, Implantation; Placenta, Luteal Phase Defect, Luteal Support, Pregnancy Loss

Keywords

progesterone, implantation, pregnancy, abortion

Brief summary

This study evaluates the clinical efficacy of 3 different luteal phase support in patients undergoing frozen-thawed embryo transfer cycles. Endometrium preparation will be hormone replacement in all cycles. Starting from day 11, group 1 will receive 100 mg micronized progesterone parenteral daily injections, group 2 will receive 90 mg bioadhesive gel vaginal twice daily and group 3 will receive 40 mg oral dydrogesterone daily tablets.

Detailed description

In natural pregnancy, successful implantation and pregnancy necessitates well-functioning corpus luteum. Luteal phase support (LPS) is critical in assisted conception cycles particularly for replacement frozen embryo transfer cycles owing to lack of corpus luteum. 3 different LPS options have been suggested: * Progesterone in oil (intramuscular injections) is rapidly absorbed after i.m. injection and high progesterone plasma concentrations are reached after approximately 2h. Despite satisfactory plasma levels, the possible side-effects of pain and swelling are limiting the use. * Vaginal application of progesterone is widely accepted with satisfactory endometrial levels and patient convenience. However, increased vaginal discharge and possible vaginal irritation are the most common side effects. * Oral administration of synthetic progesterone (dydrogesterone) would offer a convenient way of progesterone administration. Better bioavailability than natural progesterone and less cost makes dydrogesterone preferable. Also, good quality evidence revealed satisfactory outcomes in fresh embryo transfer cycles. However, there is lack of good quality evidence for dydrogesterone as a LPS in frozen-thawed cycles. The investigator's aim is to compare 3 widely used LPS in frozen-thawed embryo transfer cycles. Following allocation of the subjects, hormone replacement will be scheduled for the endometrial preparation. Briefly; On day 2 of menstrual bleeding, endometrial preparation with oral estradiol (E2) (2 mg twice daily) will be initiated. Approximately 10 days after initiation of E2 administration, the subject will undergo a transvaginal ultrasound examination to assess endometrial development and serum progesterone (P) level will be checked. Once the subject achieved a trilaminar endometrium with a thickness of \>7 mm with serum P levels \<1.5 ng/ml, she will start the progesterone treatment to which she will be randomized to one of the 3 arms. After 3 days of P treatment along with E2 pills, cleavage embryo transfer will be performed. If the subject will receive blastocyst, 5 days of P treatment will be scheduled. If these criteria were not met at the first evaluation, she will allowed up to 10 additional days (20 days total) of estrogen stimulation.

Interventions

DRUGDydrogesterone 10Mg Tablet (duphaston)

40 mg daily oral tablets

DRUGProgesterone 50Mg/mL Oil

100 mg daily intramuscular injections

180 mg daily vaginal gels

Sponsors

Centrum Clinic IVF Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* woman aged 20-40 years * Having available blastocyst(s) cryopreserved by vitrification method.

Exclusion criteria

* requirement for fresh embryo(s); * presence of any clinically relevant systemic disease contraindicated for assisted reproduction or pregnancy * history of more than three failed cycles of IVF * history of recurrent abortions * allergy history for relevant drugs * body mass index of \<18 or \>38 kg/m2 at screening * current breastfeeding or pregnancy * refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests * trophectoderm or blastomere biopsy of the blastocyst(s) to be transferred

Design outcomes

Primary

MeasureTime frameDescription
ongoing pregnancy rate12th week of pregnancyfetal cardiac activity beyond 12th week of gestation

Secondary

MeasureTime frameDescription
clinical pregnancy rate6th week of pregnancyfetal cardiac activity
abortion rateduring first 10 weeks of gestationmiscarriage of the pregnancy pregnancy recently confirmed with positive beta hCG blood test

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026