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The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.

C

Central Jutland Regional Hospital

Status and phase

Unknown
Phase 4

Conditions

Infertility

Treatments

Drug: MENOPUR; GONAL-F

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

To evaluate the effect of LH-activity supplementation during the early follicular phase in GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by comparing different combinations with HP-HMG and r-FSH.

Sex

Female

Ages

18 to 38 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Females between the ages of 18- 38 years (both included) at the time of randomisation
  • Patients for whom treatment with gonadotrophins and GnRH agonist (long protocol) in IVF setting is considered appropriate according to the criteria of the participating centre
  • Infertility for at least 1 year before randomisation (except for tubal infertility)
  • A maximum of two previous consecutive unsuccessful IVF cycles (i.e. not resulting in an ongoing pregnancy
  • 25- 34 days of menstruation cycle
  • Body mass index (BMI) < 29 kg/m2

Exclusion criteria

  • Any clinically significant systemic disease (e.g., insulin dependent diabetes)
  • Endocrine or metabolic abnormalities (pituitary, adrenal, thyroid, pancreas, liver, or kidney) which can compromise participation in the study
  • Any concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), prostaglandin inhibitors (NSAIDs, including aspirin) and psychotropic agents (phenothiazine's, major tranquillisers) at the time of study entry. Note: these medications are disallowed for the study duration.
  • Presence of clinically significant uterine fibroids
  • Undiagnosed vaginal bleeding
  • Tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
  • Pregnancy, lactation or contraindication to pregnancy - must be confirmed by negative urinary pregnancy test at randomisation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Peter Humaidan, M.D.

Data sourced from clinicaltrials.gov

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