CClinicalTrials.gg
Status unknownNCT04512807Updated Oct 22, 2020

AMH and Pregnancy Outcome in IVF

An observational study in AMH, sponsored by Al Baraka Fertility Hospital. Status unknown. Open to female participants aged 22 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Al Baraka Fertility Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
650
Ages
22 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • AMH
03

Who can participate

Ages eligible
22 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with low or very low AMH

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
650 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testAMH

    AMH \& PREGNANCY

05

What researchers measure

Primary outcomes

  1. pregnancy test

    B-HCG

    Time frame: 2 weeks

  2. clinical pregnancy rate

    fetal heart activity

    Time frame: 4 weeks

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT04512807
Lead sponsor
Al Baraka Fertility Hospital
Responsible party
Dr. Kamal Rageh (doctor , medical director, Al Baraka Fertility Hospital) — Principal investigator
First posted
Aug 14, 2020
Start date
Oct 15, 2020 (estimated)
Primary completion
Nov 20, 2020 (estimated)
Completion
Nov 25, 2020 (estimated)
Last update
Oct 22, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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