Clinical trial · Interventional
Corifollitropin Alfa Application in PCOS Patients
Corifollitropin Alfa in Combination With Elective Cryopreservation of All Embryos After GnRH Agonist Triggering of Final Oocyte Maturation in PCOS Patients- a Prospective, Observational Proof-of -Concept Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Corifollitropin alfa, single dose administered sustains multiple follicular development for 7 days. However, It may induce ovarian hyperstimulation syndrome (OHSS), especially in high responder women such as patients of polycystic ovary syndrome (PCOS). In GnRH antagonist protocol with agonist triggering of final oocyte maturation, following embryo cryopreservation can almost eliminate the risk of OHSS. To decrease the injection burden and prevent OHSS in PCOS patients undergoing IVF treatment, ovarian hyperstimulation with Corifollitropin alfa in GnRH antagonist protocol and GnRH agonist triggering of final oocyte maturation, following elective embryo cryopreservation was designed in this study. The purpose of this trial was conducted to confirmed whether this novel protocol could prevent OHSS, decreased the injection burden of PCOS patients and single dose corifollitropin alfa could support multiple follicular growth for 7 days.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| In Vitro Fertilization | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Corifollitropin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Corifollitropin in PCOS
- description
- In GnRH antagonist protocol, a single dose corifollitropin alfa was administered for ovarian stimulation following rFSH daily injection to stimulate follicle development. GnRH agonist was given to trigger final oocyte maturation when three follicles reached 17 mm in size. The IVF or ICSI was planned then all embryos were elective cryopreserved.
- interventionNames
- Drug: Corifollitropin alfa
Primary outcomes (1)
- measure
- Number of participants with severe OHSS
- timeFrame
- one month
- description
- The patients were assessed for signs and symptoms of OHSS on 3, 6, and 9 days after oocyte retrieval including history taking, physical examination, ultrasound scan, and blood tests for hematocrit, complete blood counts.The severity of OHSS was according to the classification of Golan et al. \[Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E.Ovarian hyperstimulation syndrome: an update review. ObstetGynecol Surv. 1989;44:430-40\].
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 38 Years
Show eligibility criteria text
Inclusion Criteria: The diagnosis of PCOS was according Rotterdam criteria ( twoi of three) included: * chronic anovulation manifested by the symptoms of oligomenorrhoea * ultrasonographic evidence of polycystic enlarged ovary with over 10 peripherally located follicles of 3-8mm diameter around a dense central stroma * hyperandrogenaemia (serum testosterone concentrations over 0.8 ng/ml) or clinical hyperandrogenism. Exclusion Criteria: * A diagnosis of congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumours, hyperprolactinaemia and thyroid dysfunction were all excluded. * patients older than 38 years or with serum FSH level over 12 mIU/ml. * patients wiht previous ovarian surgery * husband with non-obstructive azoospermia
References
Publications (0)
Data not yet available