Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome

khalid abd aziz mohamed

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility

Treatments: Drug: Calcium Dobesilate; Other: coasting

Study type: Interventional

Funder types: Other

Identifiers

NCT02290002

ahmed-khalid 8

Details and patient eligibility

About

The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).

Full description

Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 3 weeks ; while in group B (Coasting group), coasting (withholding gonadotrophins while maintaining pituitary suppression) follow up every day by measuring E2 for 3 days then either giving triggering or cycle cancellation is done

Enrollment: 200 patients

Sex: Female

Ages: 23 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infertile women undergoing intracytoplasmic sperm injection or polycystic ovarian syndrome (PCO) with one of the following:

  • Presence of more than 20 follicles by ultrasound
  • E2 more than 3000 pg/ml
  • Retrieval of more than 15 follicles

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

group A

Active Comparator group

Description:

In group A, (Calcium Dobesilate group), 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given from at day of HCG injection and for 21 days.

Treatment:

Drug: Calcium Dobesilate

group B

Active Comparator group

Description:

In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done

Treatment:

Other: coasting