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PErsonalized Addition of Recombinant LH in suboptimal responders >35 years old (POSEIDON group 2). A randomized controlled trial
EU CTIS ID: 2024-514035-19-00
What this study is testing
The aim of the study is to compare serum progesterone levels as well as P4/E2 ratio on the day of ovulation triggering following treatment with 300 IU of rhFSH and 150 IU of rhLH (Pergoveris®) versus 300 IU of rhFSH alone (Gonal-F®) in a GnRH antagonist protocol, in women with low ovarian sensitivity belonging to POSEIDON group 2, who demonstrated a previous suboptimal response with a starting dose of ≤225 IU with any gonadotropin in a previous cycle with a GnRH antagonist protocol.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- POSEIDON group 2 patients
- Able and willing to sign the Patient Consent Form and adhere to study visitation schedule.
- Age: ≥ 35 years ≤40 years old.
- antral Follicle Count (AFC) ≥5 and /or antimullerian hormone (AMH) ≥1.2 ng/mL.
- <4 or 4-9 oocytes retrieved in a previous IVF/ICSI cycle with a starting dose of ≤225IU with any gonadotropin under a GnRH antagonist protocol.
- Up to 3 previous ovarian stimulation cycles with a starting dose of ≤225IU in which dose adjustments during stimulation did not exceed 300IU.
You likely can't join if
- Poor ovarian responders according to the Bologna criteria.
- Contraindications for the use of medicine used for ovarian stimulation (gonadotropins, GnRH antagonist, progesterone vaginal gel)
- Recent history of severe disease requiring regular treatment (Clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication to pregnancy).
- PGT-a (Preimplantation Genetic Testing for Aneuploidies).
- TESA or TESE (Testicular Sperm Aspiration or Testicular Sperm Extraction)
- PCOS patients according to the Rotterdam criteria.
See the full eligibility criteria
- POSEIDON group 2 patients
- Able and willing to sign the Patient Consent Form and adhere to study visitation schedule.
- Age: ≥ 35 years ≤40 years old.
- antral Follicle Count (AFC) ≥5 and /or antimullerian hormone (AMH) ≥1.2 ng/mL.
- <4 or 4-9 oocytes retrieved in a previous IVF/ICSI cycle with a starting dose of ≤225IU with any gonadotropin under a GnRH antagonist protocol.
- Up to 3 previous ovarian stimulation cycles with a starting dose of ≤225IU in which dose adjustments during stimulation did not exceed 300IU.
- Ovarian stimulation for IVF/ICSI
- Poor ovarian responders according to the Bologna criteria.
- Contraindications for the use of medicine used for ovarian stimulation (gonadotropins, GnRH antagonist, progesterone vaginal gel)
- Recent history of severe disease requiring regular treatment (Clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication to pregnancy).
- PGT-a (Preimplantation Genetic Testing for Aneuploidies).
- TESA or TESE (Testicular Sperm Aspiration or Testicular Sperm Extraction)
- PCOS patients according to the Rotterdam criteria.
- AFC>20.
- Age >40 or <35 years old.
- Women with >10 oocytes retrieved in a previous IVF/ICSI cycle with 150-225 IU starting dose.
- Women who required dose adjustments during stimulation >300 IU with any gonadotropin in their previous cycle
- Uterine abnormalities.
- Recent history of any current untreated endocrine abnormality.
- Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.