The role of progesterone support and genetic polymorphisms for inflammatory cytokines on the risk of developing ovarian hyperstimulation syndrome (OHSS) in women undergoing In-Vitro fertilisation/Intracytoplasmic sperm injection (IVF, IVF-ICSI) treatment for infertility. - Progesterone support,cytokine polymorphisms & risk of OHSS in IVF/ICSI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012666-31-GB

Enrollment

360

Registered

2009-10-20

Start date

2009-11-11

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Hyperstimulation syndrome MedDRA version: 14.0 Level: PT Classification code 10033266 Term: Ovarian hyperstimulation syndrome System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Gestone Product Name: Gestone Pharmaceutical Form: Solution for injection Trade Name: CYCLOGEST Product Name: Cyclogest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women aged between 18-39years with a diagnosis of infertility requiring IVF/ICSI treatment Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Adverse reaction to progesterone. Hypersensitivity to progestins, thrombophlebitis, cerebral haemorrhage, severe hepatic dysfunction.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Is there a genetic risk factor that predisposes women to ovarian hyperstimulation syndrome? What are the effects of different progesterone preparations in the luteal phase on serum levels of metabolite / biochemical mediators of OHSS? Is there a difference in the pharmacokinetic properties of different progesterone preparations and if so does this impact on ovarian function? Does the treatment outcome (implantation, clinical pregnancy, ongoing pregnancy and first trimester miscarriage rates) differ with the different progesterone preparations? ; Primary end point(s): Percentage of women developing OHSS in the luteal phase OHSS as defined by Golan’s classification (Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E. Ovarian hyperstimulation syndrome: an update review. Obstet Gynecol Surv 1989;44(6):430-40) The classification uses a combination of patients symptoms and signs , objective ultrasound measurements and blood indicies. ; Main Objective: Is there a difference in the severity of OHSS in women undergoing IVF or ICSI when different progesterone preparations are used to support the embryo after transfer into the uterus(womb)?	—

Measure

Time frame

Secondary Objective: Is there a genetic risk factor that predisposes women to ovarian hyperstimulation syndrome? What are the effects of different progesterone preparations in the luteal phase on serum levels of metabolite / biochemical mediators of OHSS? Is there a difference in the pharmacokinetic properties of different progesterone preparations and if so does this impact on ovarian function? Does the treatment outcome (implantation, clinical pregnancy, ongoing pregnancy and first trimester miscarriage rates) differ with the different progesterone preparations? ; Primary end point(s): Percentage of women developing OHSS in the luteal phase OHSS as defined by Golan’s classification (Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E. Ovarian hyperstimulation syndrome: an update review. Obstet Gynecol Surv 1989;44(6):430-40) The classification uses a combination of patients symptoms and signs , objective ultrasound measurements and blood indicies. ; Main Objective: Is there a difference in the severity of OHSS in women undergoing IVF or ICSI when different progesterone preparations are used to support the embryo after transfer into the uterus(womb)?

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026