Luteal Support in Frozen-Thawed Embryo Transfer Cycles

NCT03948022 | Completed Phase 4

• 1 other identifier: centrumtupbebek
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

progesterone; implantation; pregnancy; abortion

Outcome Measures

Primary Outcomes (1)

• ongoing pregnancy rate

  fetal cardiac activity beyond 12th week of gestation

  12th week of pregnancy

Secondary Outcomes (2)

• clinical pregnancy rate

  6th week of pregnancy

• abortion rate

  during first 10 weeks of gestation

Study Arms (3)

intramuscular progesterone

ACTIVE COMPARATOR

progestan (progesterone) 50 mg/ml ampoules, 2 ampoules (100 mg) intramuscular starting from day 11 of the endometrial preparation cycle.

Drug: Progesterone 50Mg/mL Oil

vaginal progesterone

ACTIVE COMPARATOR

crinone %8 bioadhesive gel (progesterone) 90 mg, twice daily (180 mg/day) starting from day 11 of the endometrial preparation cycle.

Drug: Crinone 8% Vaginal Gel

oral dydrogesterone

EXPERIMENTAL

oral dydrogesterone (progesterone) 10 mg tablets, 2x2 (40 mg total)

Drug: Dydrogesterone 10Mg Tablet (duphaston)

Interventions

Dydrogesterone 10Mg Tablet (duphaston) DRUG

40 mg daily oral tablets

oral dydrogesterone

Progesterone 50Mg/mL Oil DRUG

100 mg daily intramuscular injections

intramuscular progesterone

Crinone 8% Vaginal Gel DRUG

180 mg daily vaginal gels

vaginal progesterone

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centrum Clinic IVF Center: lead

Study Sites (1)

Ufuk University School of Medicine

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• Devine K, Richter KS, Widra EA, McKeeby JL. Vitrified blastocyst transfer cycles with the use of only vaginal progesterone replacement with Endometrin have inferior ongoing pregnancy rates: results from the planned interim analysis of a three-arm randomized controlled noninferiority trial. Fertil Steril. 2018 Feb;109(2):266-275. doi: 10.1016/j.fertnstert.2017.11.004. Epub 2018 Jan 17.

  PMID: 29338855 RESULT

• Griesinger G, Blockeel C, Sukhikh GT, Patki A, Dhorepatil B, Yang DZ, Chen ZJ, Kahler E, Pexman-Fieth C, Tournaye H. Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2212-2221. doi: 10.1093/humrep/dey306.

  PMID: 30304457 RESULT

• Zarei A, Sohail P, Parsanezhad ME, Alborzi S, Samsami A, Azizi M. Comparison of four protocols for luteal phase support in frozen-thawed Embryo transfer cycles: a randomized clinical trial. Arch Gynecol Obstet. 2017 Jan;295(1):239-246. doi: 10.1007/s00404-016-4217-4. Epub 2016 Oct 19.

  PMID: 27761732 RESULT

MeSH Terms

Interventions

Dydrogesterone; Tablets; Progesterone; Oils; Crinone; Vaginal Creams, Foams, and Jellies

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Pregnenediones; Pregnenes; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Lipids; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Emre Pabuccu, Assoc. Prof.

  Ufuk University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: June 30, 2021
• Primary Completion: December 18, 2021
• Study Completion: December 20, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

TU (1)