Study Summary
This trial will compare the two different protocols for controlled ovarian stimulation in patients with diminished ovarian reserve.
Eligible Conditions
- Infertility
- In Vitro Fertilization
- Diminished Ovarian Reserve
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: 40 weeks post embryo transfer
Week 40
Live birth rate
Day 5
Blastocyst development rate
First day after oocyte retrieval
Number of mature (Metaphase II) oocytes retrieved
Number of oocytes cumulus complexes retrieved
Oocyte fertilization rate
Five to seven weeks post embryo transfer
Clinical pregnancy rate
From the first day of injections, through the day of oocyte retrieval
Duration of stimulation (days)
Total FSH dosage (IU) used
Two weeks post embryo transfer
Implantation rate
When biopsy results return, usually within four weeks after oocyte retrieval
Embryo ploidy status
Within two weeks of cycle start
Cycle cancellation rate
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Luteal phase ovarian stimulation (LPOS)
1 of 2
Luteal estradiol priming protocol
1 of 2
Active Control
142 Total Participants · 2 Treatment Groups
Primary Treatment: Luteal phase ovarian stimulation (LPOS) · No Placebo Group · N/A
Luteal phase ovarian stimulation (LPOS)
Procedure
ActiveComparator Group · 1 Intervention: Timing of injectable gonadotropins · Intervention Types: ProcedureLuteal estradiol priming protocol
Procedure
ActiveComparator Group · 1 Intervention: Timing of injectable gonadotropins · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 40 weeks post embryo transfer
Who is running the clinical trial?
Northwell HealthLead Sponsor
425 Previous Clinical Trials
493,388 Total Patients Enrolled
3 Trials studying Infertility
465 Patients Enrolled for Infertility
Eligibility Criteria
Age 20 - 45 · Female Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Pennsylvania | 50.0% |
| Florida | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Northwell Fertility | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
References
- Lin LT, Vitale SG, Chen SN, Wen ZH, Tsai HW, Chern CU, Tsui KH. Luteal Phase Ovarian Stimulation May Improve Oocyte Retrieval and Oocyte Quality in Poor Ovarian Responders Undergoing In Vitro Fertilization: Preliminary Results from a Single-Center Prospective Pilot Study. Adv Ther. 2018 Jun;35(6):847-856. doi: 10.1007/s12325-018-0713-1. Epub 2018 Jun 4.
- Wu Y, Zhao FC, Sun Y, Liu PS. Luteal-phase protocol in poor ovarian response: a comparative study with an antagonist protocol. J Int Med Res. 2017 Dec;45(6):1731-1738. doi: 10.1177/0300060516669898. Epub 2017 Jan 16.
- Zhang W, Wang M, Wang S, Bao H, Qu Q, Zhang N, Hao C. Luteal phase ovarian stimulation for poor ovarian responders. JBRA Assist Reprod. 2018 Sep 1;22(3):193-198. doi: 10.5935/1518-0557.20180045.
- Wei LH, Ma WH, Tang N, Wei JH. Luteal-phase ovarian stimulation is a feasible method for poor ovarian responders undergoing in vitro fertilization/intracytoplasmic sperm injection-embryo transfer treatment compared to a GnRH antagonist protocol: A retrospective study. Taiwan J Obstet Gynecol. 2016 Feb;55(1):50-4. doi: 10.1016/j.tjog.2015.07.001.
- Mary Rausch, MD 2020. "The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04447872.
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