IVF Clinical Trial - Micronized Progesterone vs Gonadotropin-releasing

Status Completed

Clinical Trial Summary

To examine whether the number of euploid embryos following ovarian stimulation with micronized progesterone is equivalent as compared with the number of embryos after ovarian stimulation with the use of a GnRH antagonist in patients undergoing ovarian stimulation for IVF or intracytoplasmatic sperm injection (ICSI).

Clinical Trial Description

The pre-ovulatory surges of GnRH and LH are activated by increased concentrations of circulating estradiol, but ovulation is blocked when progesterone concentrations are elevated, due to a central inhibition of the GnRH surge. Although traditionally GnRH has been traditionally considered the drug of choice to control endogenous LH in controlled ovarian stimulation (COS) cycles, recently, micronized progesterone has been shown to be an effective oral alternative for preventing premature LH surges during COS in women undergoing IVF/ICSI treatments, with excellent results, whereas their safety during pregnancy is well-established. This novel protocol, has several advantages (good tolerance, user convenience, and cost reduction), that are very attractive when it comes to establishing a convenient user regimen in combination with a ''freeze all'' strategy. However, the comparative efficacy of this novel protocol with the more universal use of GnRH-antagonist protocol for the treatment of IVF patients in terms of embryo ploidy has never been evaluated up to date. The current study aims, for the first time, to examine whether the number of euploid embryos following ovarian stimulation with micronized progesterone is equivalent as compared with the number of embryos after ovarian stimulation with the use of a GnRH antagonist in patients undergoing ovarian stimulation for IVF/ICSI. If efficacy would prove to be similar, with no impact on the chromosomal constitution of embryos, there will be obvious advantages for the preferential use of micronized progesterone over the antagonist protocol: oral administration is preferred over subcutaneous injection, and total cost of medication would be lower. This would be particularly interesting for the future in all "freeze all" protocols such as women undergoing ovarian stimulation for fertility preservation, preimplantation genetic screening and oocyte donation programs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04108039
Study type	Interventional
Source	Institut Universitari Dexeus
Contact
Status	Completed
Phase	N/A
Start date	September 25, 2019
Completion date	May 15, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03607409` - Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
Recruiting	`NCT02312076` - GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles	Phase 4
Terminated	`NCT02161861` - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study	N/A
Completed	`NCT03287479` - Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)	N/A
Terminated	`NCT03522350` - Randomized Trial Comparing EmbryoScope With EmbryoScope+.	N/A
Completed	`NCT04496284` - Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen	N/A
Completed	`NCT03623659` - pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts	N/A
Completed	`NCT03895099` - New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors	Phase 3
Active, not recruiting	`NCT04142112` - Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation	N/A
Completed	`NCT03152643` - Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer	N/A
Recruiting	`NCT03683771` - Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
Recruiting	`NCT03161119` - Comparing Two Different Embryo Transfer Catheters	N/A
Completed	`NCT03678571` - Oocyte Vitrification Aided With Latrunculin A	N/A
Completed	`NCT03678597` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)	N/A
Completed	`NCT03677492` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)	N/A
Completed	`NCT03678610` - Handling Medium for ICSI With Ionomycin and Latrunculin A	N/A
Completed	`NCT03678584` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)	N/A
Completed	`NCT03678558` - Oocyte Vitrification Aided With Cytochalasin B	N/A
Completed	`NCT03678818` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)	N/A
Completed	`NCT01977144` - Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles. — Prog_STIM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms