Anti-Müllerian Hormone (AMH) Measured With Fully Automated Assay Versus AFC in the Prediction of Ovarian Response

NCT04168892 | Completed

• 1 other identifier: 01/MR/19
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this prospective, observational, multivariate study will be to compare the reliability of automated AMH (measured with Access AMH assay, Beckman-Coulter Diagnostics, USA) with that of antral follicle count (AFC) evaluated ultrasonographically always by the same operator and with the same ultrasound scanner, in terms of the number of oocytes recovered from oocyte sampling in couples subjected to in vitro fertilization.

Conditions

Ovarian Response

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  The number of oocytes collected after oocyte retrieval

  13-15 days starting from the first day of the cycle

Secondary Outcomes (1)

• Cumulative clinical pregnancy rate per patient

  28-32 days after the oocyte retrieval

Study Arms (2)

Female age ≤ 35 years: 150 IU of HMG

For controlling the effect of the starting dose on the number of retrieved oocytes, the patients will be divided in two groups based on their age. For the patients with an age ≤ 35 years, COS will be carried out by daily injections of 150 IU of Human Menopausal Gonadotropins (HMG) and will be started on the 3rd day of the cycle. The starting dose will be maintained for the first 5 days and followed by individual dose-adjustments according to the patient's follicular response. The pituitary suppression will be obtained by the administration of the Gonadotropin-releasing Hormone (GnRH) antagonist ganirelix (0.25 mg per day), starting from the 6th day of the ovarian stimulation until the day of the induction of the final oocyte maturation. Highly purified urinary human Chorionic Gonadotropin (hCG) 10.000 IU will be used to induce final oocyte maturation. In case of OHSS risk, the final oocyte maturation will be obtained by using a GnRH agonist (buserelin acetate), 0.5 mg subcutaneously.

Drug: 150 IU of HMG in patients with age ≤ 35 years

Female age >35 years: 225 IU of HMG

In order to control the effect of the starting dose on the number of retrieved oocytes, the patients will be divided in two groups based on their age. For the patients with an age \>35 years, the controlled ovarian stimulation will be carried out by daily injections of 225 IU of HMG and will be started on the 3rd day of the cycle. The starting dose will be maintained for the first 5 days and followed by individual dose-adjustments according to the patient's follicular response. The pituitary suppression will be obtained by the administration of the GnRH antagonist ganirelix (0.25 mg per day), starting from the 6th day of the ovarian stimulation until the day of the induction of the final oocyte maturation. Highly purified urinary hCG 10.000 IU will be used to induce final oocyte maturation. In case of OHSS risk, the final oocyte maturation will be obtained by using a GnRH agonist (buserelin acetate), 0.5 mg subcutaneously.

Drug: 225 IU of HMG in patients with age > 35 years

Interventions

150 IU of HMG in patients with age ≤ 35 years DRUG

The use of a different starting dose, based on the female age, derives from the necessity to control the effect of a variable starting dose on the primary outcome.

Female age ≤ 35 years: 150 IU of HMG

225 IU of HMG in patients with age > 35 years DRUG

The use of a different starting dose, based on the female age, derives from the necessity to control the effect of a variable starting dose on the primary outcome.

Female age >35 years: 225 IU of HMG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This trial will involve couples attending their first IVF/ICSI cycle.

You may qualify if:

• BMI between 18 and 30 kg/m2, basal serum day 3 FSH ≤ 15 IU/l, normal regular menstrual cycles, ranging from 25 to 33 days in length, normal thyroid-stimulating hormone (TSH) and prolactin levels, normal uterine cavity as assessed by hysteroscopy or sonohysterography or three-dimensional ultrasound and presence of both ovaries.

You may not qualify if:

• irregular menstrual cycles, severe endometriosis, defined as stage III-IV of the American Society for Reproductive Medicine (ASRM) revised classification, previous ovarian surgery, presence of ovarian cysts, polycystic ovary syndrome, use of hormonal contraception in the previous 3 months and use of gonadotrophins in the previous 3 months, any known metabolic or endocrinological disease

Sponsors & Collaborators

• Andros Day Surgery Clinic: lead

Study Sites (1)

ANDROS Day Surgery Clinic, Reproductive Medicine Unit

Palermo, 90144, Italy

Location

Related Publications (5)

• Zhang Y, Xu Y, Xue Q, Shang J, Yang X, Shan X, Kuai Y, Wang S, Zeng C. Discordance between antral follicle counts and anti-Mullerian hormone levels in women undergoing in vitro fertilization. Reprod Biol Endocrinol. 2019 Jul 4;17(1):51. doi: 10.1186/s12958-019-0497-4.

  PMID: 31272468 BACKGROUND

• Pearson K, Long M, Prasad J, Wu YY, Bonifacio M. Assessment of the Access AMH assay as an automated, high-performance replacement for the AMH Generation II manual ELISA. Reprod Biol Endocrinol. 2016 Feb 16;14:8. doi: 10.1186/s12958-016-0143-3.

  PMID: 26879773 BACKGROUND

• Allegra A, Marino A, Volpes A, Coffaro F, Scaglione P, Gullo S, La Marca A. A randomized controlled trial investigating the use of a predictive nomogram for the selection of the FSH starting dose in IVF/ICSI cycles. Reprod Biomed Online. 2017 Apr;34(4):429-438. doi: 10.1016/j.rbmo.2017.01.012. Epub 2017 Jan 23.

  PMID: 28189417 BACKGROUND

• van Tilborg TC, Oudshoorn SC, Eijkemans MJC, Mochtar MH, van Golde RJT, Hoek A, Kuchenbecker WKH, Fleischer K, de Bruin JP, Groen H, van Wely M, Lambalk CB, Laven JSE, Mol BWJ, Broekmans FJM, Torrance HL; OPTIMIST study group. Individualized FSH dosing based on ovarian reserve testing in women starting IVF/ICSI: a multicentre trial and cost-effectiveness analysis. Hum Reprod. 2017 Dec 1;32(12):2485-2495. doi: 10.1093/humrep/dex321.

  PMID: 29121350 BACKGROUND

• Andersen AN, Witjes H, Gordon K, Mannaerts B; Xpect investigators. Predictive factors of ovarian response and clinical outcome after IVF/ICSI following a rFSH/GnRH antagonist protocol with or without oral contraceptive pre-treatment. Hum Reprod. 2011 Dec;26(12):3413-23. doi: 10.1093/humrep/der318. Epub 2011 Sep 27.

  PMID: 21954280 BACKGROUND

MeSH Terms

Interventions

Aging

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2019
• First Posted: November 19, 2019
• Study Start: September 20, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)