Evaluation of Different Luteal Phase Support Methods in Patients With Poor Ovarian Response

NCT02798653 | Unknown Phase 3 DMC

• 1 other identifier: Royan-Emb-024
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized clinical trial to investigate the efficacy of different luteal phase support methods in patients with poor ovarian response undergoing IVF and intracytoplasmic sperm injection (ICSI) cycles. The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan institute. The study is conducted according to the Declaration of Helsinki for medical research. All participants provide informed consent after counseling for infertility treatments and routine IVF/ICSI programs.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Evaluation the clinical pregnancy rate at least 4 weeks after embryo transfer.

  4 weeks

Secondary Outcomes (3)

• Implantation rate

  4 weeks

• chemical pregnancy rates

  2 weeks

• miscarriage rate

  12 weeks

Study Arms (3)

Choriomon®

EXPERIMENTAL

subjects receive 1,500 IU of hCG (Choriomon®; IBSA) intramuscular (IM) on the embryos transfer (ET) day, as well as 4 days after the embryos transfer for luteal support

Drug: Choriomon® injection

Choriomon®+Endometrin ®

EXPERIMENTAL

patients will receive 1,500 IU of hCG (Choriomon®; IBSA) (IM) on the ET day, as well as 3 and 6 days after the transfer along with Endometrin ® vaginal tablets (Ferring Pharmaceuticals Ltd., Germany) 100 mg twice daily for luteal support from the day of oocyte pickup to the day of the pregnancy test.

Drug: Choriomon® injection+Endometrin ®

Endometrin ®

EXPERIMENTAL

patients will receive only Endometrin ® vaginal tablets (Ferring Pharmaceuticals Ltd., Germany) 100 mg twice daily for luteal support from the day of oocyte pickup to the day of the pregnancy test.

Drug: Endometrin ® vaginal tablets

Interventions

Choriomon® injection DRUG

Intramuscular injection of 1,500 IU of hCG (Choriomon®; IBSA) on the embryos transfer (ET) day, as well as 4 days after the embryos transfer for luteal support

Choriomon®

Choriomon® injection+Endometrin ® DRUG

Intramuscular injection of 1,500 IU of hCG (Choriomon®; IBSA) on the ET day, as well as 3 and 6 days after the transfer along with Endometrin ® vaginal tablets (Ferring Pharmaceuticals Ltd., Germany) 100 mg twice daily for luteal support from the day of oocyte pickup to the day of the pregnancy test.

Choriomon®+Endometrin ®

Endometrin ® vaginal tablets DRUG

Endometrin ® vaginal tablets (Ferring Pharmaceuticals Ltd., Germany) 100 mg twice daily for luteal support from the day of oocyte pickup to the day of the pregnancy test.

Endometrin ®

Eligibility Criteria

• Age: 40 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of poor ovarian response (POR), according to Bologna criteria:
• the patients have at least two of the following criteria:
• age over 40 years;
• a history of ovarian surgery;
• previous treatment using conventional protocols that yielded less than three oocytes;
• antral follicle count of less than 5 on menstrual cycle day 2-3; and basal serum FSH concentration between 10 and 19 IU/l or serum anti-Müllerian hormone level less than 1 ng/ml.

You may not qualify if:

• Female age over 45 years old 2- Ovarian failure including basal FSH above 20 IU/l or no antral follicle by ultrasound examination 3- Severe male factor (Azoospermia) 4- Endometriosis diagnosis and the presence of hydrosalpinges 5- Uterine factor (polyps, myoma and previous myomectomy, …) 6- Patients with cardiovascular disease and/or uncontrolled systemic or endocrine diseases 7- Patients with repeated implantation failures and repeated miscarriages. 8- Female smokers

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

RECRUITING

Related Publications (1)

• Madani T, Arabipoor A, Ramezanali F, Khodabakhshi S, Zolfaghary Z. The Effects of Three Methods of Luteal Phase Support on Pregnancy Outcomes in Poor Ovarian Responders: A Randomized Clinical Trial. Int J Fertil Steril. 2025 Jan 5;19(1):10-16. doi: 10.22074/ijfs.2024.2007292.1500.

  PMID: 39827385 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Hamid Gourabi, p

  Head of Royan Institute

  STUDY CHAIR

• Tahere Madani, MD

  Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

  STUDY DIRECTOR

• Fariba Ramezani, MD

  Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

  PRINCIPAL INVESTIGATOR

• Arezoo Arabipour, M.S.c

  Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasser Aghdami, MD,PhD

CONTACT

(+98)23562000; nasser.aghdami@royaninstitute.org

Leila Arab, MD

CONTACT

(+98)23562000; leara91@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 27, 2018

Record last verified: 2016-06

Locations

IR (1)