Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist (Avanti)

U

Universitair Ziekenhuis Brussel

Status and phase

Completed
Phase 4

Conditions

Fertility
Optimal Stimulation Protocol
Reproductive Endocrinology

Treatments

Drug: Progesterone
Drug: Human chorionic gonadotropin
Drug: hP-hMG
Drug: GnRH antagonist
Drug: GnRH agonist

Study type

Interventional

Funder types

Other

Identifiers

NCT01888744
2010/010

Details and patient eligibility

About

The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).

Full description

Patients will be randomized at the outpatient clinic in two groups.

Enrollment

120 patients

Sex

Female

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≤ 39 years the day of oocyte retrieval
  • BMI ≤ 29
  • cycle rank 1
  • menstrual cycle 25-36 days
  • PGD or preimplantation genetic screening (PGS) requested
  • ICSI
  • Single embryo transfer (SET) on day 5

Exclusion criteria

  • Polycystic Ovary Syndrome (PCOS) (according Rotterdam criteria)
  • Hormonal disturbances
  • Endometriosis grade III and IV

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Group 1 (GnRH agonist group)
Active Comparator group
Description:
The long GnRH agonist protocol starts on day 21 of the preceding cycle with the administration of GnRH agonist, Decapeptyl® 0,1 mg subcutaneously daily or buserelin acetate, Suprefact® 600 μg daily intranasal. The administration of highly purified human menopausal gonadotropin (hp-HMG), Menopur® 225 IU subcutaneously is started after three weeks of desensitization. The desensitization is checked by ultrasound (absence of cysts) and hormonal measurement (Estradiol levels < 80 pg/ml, FSH ≤ 10 IU/l and progesterone < 1,5ng/ml)
Treatment:
Drug: GnRH agonist
Drug: hP-hMG
Drug: Human chorionic gonadotropin
Drug: Progesterone
Group 2 (GnRH antagonist group)
Active Comparator group
Description:
Ovarian stimulation is started at day 2 of the menstrual cycle with 225 IU of HMG (Menopur ®) subcutaneously. At day 6 of the stimulation GnRH antagonist (Orgalutran®) 0,25 mg subcutaneously is added. Basal hormonal status will be confirmed in the antagonist group before starting.
Treatment:
Drug: hP-hMG
Drug: GnRH antagonist
Drug: Human chorionic gonadotropin
Drug: Progesterone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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