Evaluation of Different Luteal Phase Support Methods in Patients With Poor Ovarian Response
NCT ID: NCT02798653
Last Updated: 2018-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
210 participants
INTERVENTIONAL
2015-11-30
2019-12-31
Brief Summary
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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.
Detailed Description
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The ovarian stimulation is performed with antagonist protocol with E2 priming for all eligible patients. All women receive estrogen priming (E2 tablet) starting a week after LH surge until menses. Controlled ovarian stimulation is started on day 2 of menstrual cycle with 225 IU recombinant FSH (Gonal-F®; Serono Laboratories Ltd., Geneva, Switzerland) and 75 IU hMG (Menopur®; Ferring). The doses of gonadotropins were adjusted as ovarian response in the ultrasound monitoring. Gonadotropin releasing hormone (GnRH) antagonist (Cetrorelix acetate 0.25 mg; Cetrotide ®, USAN) is administrated to prevent premature ovulation when the lead follicle measured ≥ 12 mm and was continued until the hCG trigger. Final oocyte triggering will be done with 10000 IU of hCG (Choriomon®; IBSA). If there were or more dominant follicles, oocytes retrieval will be done under transvaginal ultrasound guidance 32-34 hours after hCG administration. Intracytoplasmic sperm injection will be performed for all metaphase II oocytes. Embryo transfer will be done under ultrasound guidance on day 3 for all patients.
On the day of oocyte pickup, patients are allocated randomly (by the blocked randomization method) into three groups to receive three different luteal support protocols and they remained on the same allocation throughout the study. Group 1, subjects receive 1,500 IU of hCG IM on the embryos transfer (ET) day, as well as 4 days after the embryos transfer. Group 2: patients will receive 1,500 IU of hCG 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. Group 3, 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. The vaginal progesterone is continued in all patients who become pregnant in all three groups until the 12th week of pregnancy. The serum ß-hCG level is checked 2 weeks after ET to confirm positive pregnancy test. Clinical pregnancies are detected with the confirmation of positive fetal heart activities by transvaginal sonography. The implantation rate is considered as the proportion of number of observed intrauterine gestational sac to number of transferred embryos. Multiple pregnancies are defined as two or more gestational sacs in the uterine cavity. Miscarriage is defined as a loss of a clinical pregnancy before the 12th week of gestation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Choriomon®
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
Choriomon® injection
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®+Endometrin ®
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.
Choriomon® injection+Endometrin ®
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.
Endometrin ®
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.
Endometrin ® vaginal tablets
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.
Interventions
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Choriomon® injection
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® injection+Endometrin ®
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.
Endometrin ® vaginal tablets
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.
Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
\-
40 Years
52 Years
FEMALE
No
Sponsors
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Royan Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Hamid Gourabi, p
Role: STUDY_CHAIR
Head of Royan Institute
Tahere Madani, MD
Role: STUDY_DIRECTOR
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Fariba Ramezani, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Arezoo Arabipour, M.S.c
Role: PRINCIPAL_INVESTIGATOR
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Locations
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Royan Institute
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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Nasser Aghdami, MD,PhD
Role: primary
Leila Arab, MD
Role: backup
References
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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.
Related Links
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Related Info
Other Identifiers
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Royan-Emb-024
Identifier Type: -
Identifier Source: org_study_id