AMH and Pregnancy Outcome in IVF

NCT04512807 | Unknown DMC

• 1 other identifier: Dr. Atyaf Aldawodi
• Study Type: observational
• Target: 650
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anti-Mu¨llerian hormone (AMH) is an established marker of ovarian reserve (La Marca et al., 2010; Nelson et al., 2009) and predicts both high and low responses in ovarian stimulation cycles (Eldar-Geva et al., 2005; Nardo et al., 2009; Nelson et al., 2007). Presently, AMH helps clinicians counsel patients prior to IVF treatment (La Marca et al., 2011), despite the fact that it fails to predict who will become pregnant (Lamazou et al., 2011; Riggs et al., 2011). It has been demonstrated that poor responders can achieve both pregnancy and live birth (Weghofer et al., 2011). There are few studies regarding extremely low AMH concentrations and live births (Fraisse et al., 2008; Tocci et al., 2009; Weghofer et al., 2011) and they present either a small number of patients or limited data describing the groups of investigated patients. Another factor affecting pregnancy rates is endometriosis, a chronic gynaecological disease characterized by the presence of functional endometrial tissue outside the uterine cavity (Koninckx et al., 1991). Many studies have reported that pregnancy rates are lower in women with endometriosis than in controls (Gupta et al., 2008; Koninckx et al., 1991 Pellicer et al., 2000). Lower AMH serum concentrations are associated with endometriosis severity (Shebl et al., 2006). The primary objective of the present study was to assess the clinical pregnancy rates in women with extremely low AMH concentrations with respect to age.

Conditions

AMH

Outcome Measures

Primary Outcomes (2)

• pregnancy test

  B-HCG

  2 weeks

• clinical pregnancy rate

  fetal heart activity

  4 weeks

Interventions

AMH DIAGNOSTIC_TEST

AMH \& PREGNANCY

Eligibility Criteria

• Age: 22 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with low or very low AMH

You may qualify if:

• Women ≥22 years age AMH is 0.5 and less Body mass index- 18.5-30 kg/m 2 The normal uterine cavity on ultrasound scan At least one good quality embryo present for transfer Women willing to comply with the clinical study protocol

You may not qualify if:

• Women ≥ 45 years age
• AMH \>0.5
• Uterine abnormalities that can compromise the IRs (e.g., endometrial polyp, fibroids, hydrosalpinx, and adenomyosis)
• Endocrine dysfunction or organ dysfunction such as liver or kidney failure.

Sponsors & Collaborators

• Al Baraka Fertility Hospital: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor , medical director

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: October 15, 2020
• Primary Completion: November 20, 2020
• Study Completion: November 25, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10