Hormone Evaluation in Artificial Reproductive Technology

NCT03737253 | Completed

• 1 other identifier: 2016_467
• Study Type: interventional
• Target: 810
• Locations: 2 countries
• Sites: 2

Brief Summary

The aim is to be able to predict the hormonal response according to gonadotropin receptor genotype and hormone type used for treatment of women undergoing in vitro fertilization or egg donation. Outcome will be measured as pregnancy success, live born babies and unwanted side effects.

Conditions

Female Infertility

Keywords

gonadotropin; receptor; assisted reproduction

Outcome Measures

Primary Outcomes (1)

• Pregnancy

  Association between pregnancy rate and genotype is evaluated

  up to 12 months after treatment

Secondary Outcomes (2)

• Number of oocytes

  up to 6 months after treatment

• live birth

  up to 12 months after treatment

Other Outcomes (2)

• Ovarian hyper stimulation syndrome

  Up to 6 months after treatment

• Poor response

  Up to 6 months after treatment

Study Arms (2)

Follitropin alpha

ACTIVE COMPARATOR

Follitropin alpha (GONAL-f, Merck-Serono, Darmstadt, Germany), injections, dosage varying 1500-2500 IU, duration 2-5 days.

Drug: Follitropin alpha; Drug: Menotropin

Menotropin

ACTIVE COMPARATOR

Menotropin (Menopur, Ferring GmbH, Kiel, Germany), injections, dosage varying 1500-2500 IU, duration 2-5 days.

Drug: Follitropin alpha; Drug: Menotropin

Interventions

Follitropin alpha DRUG

The objective is to measure the effect of the drug according to gonadotropin receptor genotype.

Also known as: Gonal F, Puregon, Urofollitropin

Follitropin alpha; Menotropin

Menotropin DRUG

The objective is to measure the effect of the drug according to gonadotropin receptor genotype.

Also known as: Menopur

Follitropin alpha; Menotropin

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Normal ovulatory cycles 26-32 days
• First and second IVF treatment
• Indication for IVF is male factor, tubal factor or unexplained infertility
• Medical indication for IVF; \>12 months unprotected intercourse

You may not qualify if:

• Anti Müllerian Hormone \<5pmol or cycle day 2-3 FSH \>12
• Endometriosis
• polycystic ovarian syndrome
• pre ovarian failure
• smoking
• male age more than 56.

Sponsors & Collaborators

• Lund University: lead
• European Commission: collaborator

Study Sites (2)

Poznan University of Medical Sciences

Poznan, Poland

Location

Reproductive Medicine Center

Malmo, 21428, Sweden

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Glycoprotein Hormones, alpha Subunit; follitropin alfa; follitropin beta; Urofollitropin; Menotropins

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Chorionic Gonadotropin; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Study Officials

• Yvonne Lundberg Giwercman, PhD

  Lund University, Lund, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients and care providers need to know the type of hormone provided in order to be able to instruct and treat the patient. However, all roles are masked regarding the genotype.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women undergoing in vitro fertilization are allocated to either menotropin (urin derivate) or recombinant follicle stimulating hormone. Inclusion criteria are: * younger than 40 years of age * more than 12 months of unprotected intercourse * normal ovulatory cycles 26-32 days * first or second IVF treatment * indication for IVF is male factor * tubal factor or unexplained infertility. Exclusion criteria are: * Anti müllerian hormone less than 5pmol or FSH more than 12 cycle day 2-3 * Endometriosis * polycystic ovarian syndrome * pre ovarian failure * smoking * male age more than 56. The succeeding treatment is according to normal procedures at respective clinic. End points are: total hormonal dosage, number of retrieved oocytes, fertilization rate, rate of blastocyst transfer, pregnancy rate, live birth rate. Adverse effects e.g overstimulation is recorded.

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 9, 2018
• Study Start: September 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: October 2, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

SE (1); PL (1)