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Clinical Trials/EUCTR2022-003049-37-BE
EUCTR2022-003049-37-BE
Active, not recruiting
Phase 1

uteal phase ovarian stimulation with Follitropin delta and dydrogesterone: a randomized cross over pilot trial - Lady De

Z Brussel0 sites50 target enrollmentOctober 4, 2022
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ConditionsVolutary women who wish to donate their oocytesTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsRekovelleDuphaston

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Volutary women who wish to donate their oocytes
Sponsor
Z Brussel
Enrollment
50
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 4, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Z Brussel

Eligibility Criteria

Inclusion Criteria

  • •Age from \= 18 to \= 36 years
  • •Body mass Index (BMI) \=18 to \< 28
  • •Signed informed consent
  • •Regular menstrual cycle length i.e. 24\-35 days
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 50
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Contraindications to the use of gonadotropins
  • •Endometriosis grade 3\-4
  • •Patients with Anti\-mullerian hormone (AMH) \<1\.1 ng/ml and/or AFC\<7
  • •Patients with Follicle Number Per Ovary (FNPO) \= 19 and/or AMH \>5ng/ml (Fraissinet A et al, 2017\)
  • •Patients under contraception with hormonal intrauterine device (IUD)
  • •Any untreated endocrine abnormality

Outcomes

Primary Outcomes

Not specified

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uteal phase ovarian stimulation with Follitropin delta and dydrogesteroneVolutary women who wish to donate their oocytesTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
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