Clinical trial

Double vs. Single Stimulation in Young Poor Prognosis Patients Followed by a Fresh Embryo Transfer. A Randomized Clinical Trial

Name

FSD-DUO-2020-02

Description

The major goal of controlled ovarian stimulation (COS) is to increase the number of oocytes harvested in order to result in the generation of a higher number of available embryos, extended embryo culture, embryo selection and finally providing higher cumulative live birth rates in infertile patients. Moreover, with the idea of the multiple waves of follicular production, we could start to take full advantage of the whole follicular cohort, and not only of the follicular wave. In the context of low prognosis women such as women with poor ovarian response where, the success rates are very low due to the low number of oocytes retrieved and consequently of viable embryos), Dual stimulation may be of great value as a tool to improve outcomes. The reported advantage of DuoStim is retrieved of more oocytes within a shorter time span, resulting in an increase in the probability of having transferable embryos increases, and theoretically reducing time to live birth as well as cycle cancellation.

Trial arms

Trial start

2020-10-30

Estimated PCD

2023-01-15

Trial end

2023-05-02

Status

Completed

Phase

Early phase I

Treatment

Double Stimulation (Elonva+rFSH) in luteal /follicular phase

Following the 2nd oocyte retrieval, the patient will start luteal phase support (LPS) with vaginal micronized progesterone 200mg x 3 times a day until the day of the pregnancy test. All embryos will be cultured until day 5 in time-lapse incubators. In case of no blastocyst in the second cycle, or in case of poor embryo quality and in case of availability of frozen embryos from the first stimulation cycle, 1 frozen blastocyst from the first cycle will be thawed and will be transferred 5 days following the 2nd oocyte retrieval. Embryo transfer will be performed in all patients with available blastocysts, except in cases of high risk of ovarian hyperstimulation syndrome (OHSS) or progesterone elevation which is considered clinically relevant on the day of human chorionic gonadotropin (hCG) trigger, in which freeze-all strategy and deferred frozen embryo transferred will be considered.

Arms:

Double Stimulation (Elonva+rFSH) in luteal /follicular phase

Conventional Stimulation (Elonva+rFSH) in follicular phase

From the day of oocyte retrieval, the patients will be asked to start the LPS with vaginal micronized progesterone 3 times a day until the day of the pregnancy test. Embryo transfer will be performed in all patients with available blastocysts, except in cases of high risk of OHSS or progesterone elevation which is considered clinically relevant on the day of hCG trigger, in which freeze-all strategy and deferred frozen embryo transferred will be considered.

Arms:

Conventional Stimulation (Elonva+rFSH) in follicular phase

Size

120

Primary endpoint

Number of good-quality blastocysts

Day of embryo transfer (9 -20 days from initiation of the last ovarian stimulation)

Eligibility criteria

Inclusion Criteria: * Poor prognosis patients according to the POSEIDON group 3 \& 4 (based on AMH) * AMH \<1.2 * age \<40 years old * BMI \>18 and \<35 kg/m2 * Body weight \>50kg (in women \<36 years old body weight \>60kg) Exclusion Criteria: * Maternal age \> 40 years * History of untreated autoimmune, endocrine or metabolic disorders * Previous ovarian cystectomy or oophorectomy * Body weight \<50kg (and body weight \<60kg in women \<36 years old)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

Updated at

2023-05-15

1 organization

2 products

1 indication

Organization

Fundación Santiago Dexeus Font

Product

Double Stimulation

Indication

infertility

Product

Conventional Stimulation