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Completed

NCT Number: NCT04695483

Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial

The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone > 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.

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Key information

Age range

25 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Enrico Papaleo

Milan, 20132, Italy

About this study

Each patient will receive a first visit for infertility where will be collected subject history and baseline information, and meet all the inclusion / exclusion criteria. Eligible patients who agreed to participate will be randomized to either long acting standard COS with corifollitropin alpha or standard COS with daily FSH in a fixed GnRH antagonist protocol. All patients will be allowed to participate in the study only once and a written informed consent will be obtained from all, following consultation and before the initiation of the treatment.

The endocrine profile of all the patients will be evaluated by analysis of serum progesterone, 17b-estradiol (E2), FSH and LH at different time points: basal condition, during stimulation, at the hCG day and at pick-up.

Transvaginal follicular aspiration will be performed by ultrasound guidance 36 hours after hCG administration. The day of pick up oocytes will be fertilized with partner's semen; after 3-5 days, on the base of its evolution, embryo will be transferred. 14 days after embryo-transfer a preg-nancy test will be performed. Follow up in case of obtained pregnancy will be done until 20 weeks of gestation and considered as ongoing pregnancy.

The entire duration of the study is 24 months, the follow up of the last patients enrolled will be 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication to IVF treatment
  • Normal BMI (18.5-24.9 kg/m2)
  • AMH level < 1.1 ng/ml and/or AFC < 5 follicles and/or < 3 oo-cytes retrieved in previous cycle
  • Regular menstrual cycles
  • Signed informed consent

Exclusion criteria

  • Freeze all cycles for abnormal bleeding
  • PCOS
  • History of untreated autoimmune
  • Endocrine or metabolic disorders
  • Ovarian cystectomy or oophorectomy
  • FSH ≥ 20 lU/L

Treatment and study plan

Corifollitropin alfa

Drug

Controlled ovarian stimulation long-acting protocol

Follitropin beta

Drug

Daily controlled ovarian stimulation protocol

Primary outcomes

  1. Premature progesterone elevation

    Time frame: day 12

    Progesterone > or equal to 1.1 ng/mL at day of trigger

Secondary outcomes

  1. Percentage of freeze-all cycles due to premature progesterone elevation

    Time frame: day 12

  2. Number of oocytes collected at ovum retrieval

    Time frame: day 14

  3. Fertilization rate

    Time frame: day 15

    Percentage of oocytes fertilized

  4. Number of embryos available

    Time frame: Day 17

  5. Pregnancy rate

    Time frame: day 30

    Beta-HCG positive

  6. Ongoing pregnancy

    Time frame: Up to 20 weeks

    Vital fetus at 20 weeks of gestation

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial

Acronym: PE-PMA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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