Clinical trial NCT03440359: Vaginal Progesterone Supplementation in Women With PCOS Undergoing Ovulation Induction With Letrozole
Official title: "Supplementation of the Luteal Phase With Vaginal Progesterone (Crinone 8%) in Women With Polycystic Ovary Syndrome Undergoing Ovulation Induction With Letrozole: A Prospective and Randomized Controlled Trial
Conditions: Polycystic Ovary Syndrome
Summary: Aromatase inhibitors such as letrozole are hypothesized to maintain normal hypothalamic/ pituitary feedback mechanisms and in the case of OI (ovulation induction) in women with PCOS, may act to increase follicular sensitivity to FSH by increasing intrafollicular androgen levels. Letrozole also may act to increase midluteal P levels presumably by induction of follicles and corpora lutea. The investigators are asking the question whether P supplementation with Crinone (8%) may have an additive beneficial effect on endometrial development in those women taking letrozole. Progesterone levels in the endometrium (tissue levels) have been documented to be significantly higher than serum levels after vaginal administration which may lead to higher pregnancy rates. In addition P has been shown to decrease LH pulse frequency which is elevated in PCOS and has been shown to down regulate endometrial androgen receptors. There have been retrospective studies showing progesterone supplementation seems to benefit both CC and letrozole treatment groups. In fact, this study showed the only pregnancies in the letrozole group were those in women who took P supplementation. However the number of cycles studied was small. There is a place for a randomized controlled trial (RCT) to determine if luteal phase P supplementation with Crinone should be used in all women using letrozole for Ovulation Induction (OI) in combination with Intrauterine Insemination (IUI) or Timed Intercourse (TI). This is currently not done in all clinical practices.
Interventions:
description: progesterone supplementation for luteal phase support administered with vaginal applicators and used instead of progesterone intramuscular injections or progesterone vaginal suppositories.
name: Progesterone Vaginal Gel 8%
other_name: Crinone 8% vaginal gel
type: Drug
description: letrozole oral tablet 2.5 mg or 5 mg administered cycle day 3-7 for ovulation induction
name: Letrozole Oral Tablet
type: Drug
description: pelvic ultrasound performed at cycle day 11 or 12 and repeated as necessary until leading follicle size is >17 mm in diameter
name: pelvic ultrasound
type: Diagnostic Test
description: ovidrel 250 mcg given when leading follicle size is > 17 mm in diameter
name: Ovidrel 250 MCG Per 0.5 ML Prefilled Syringe
other_name: recombinant hCG 250 mcg
type: Drug
description: Intrauterine insemination or timed intercourse (depending on semen parameters) performed 36-40 hours after Ovidrel
name: Intrauterine insemination or timed intercourse
type: Other
Study arms:
design_group_description: Letrrozole 2.5 to 5 mg oral tablet cycle day 3-7.Pelvic ultrasound at cycle day 11 or 12 and repeat if needed until leading follicle is >17 mm. Ovidrel 250 mcg injected sq. Timed intercourse or intrauterine insemination. No supplemental progesterone therapy in luteal phase
design_group_title: # 1- no progesterone therapy
design_group_type: Other
design_group_description: Letrrozole 2.5 to 5 mg oral tablet cycle day 3-7. Pelvic ultrasound at cycle day 11 or 12 and repeat if needed until leading follicle is >17 mm. Ovidrel 250 mcg injected sq. Timed intercourse or intrauterine insemination.Crinone 8% (progesterone) vaginal therapy was provided in luteal phase for 14 days .Administration was started the second day after intrauterine insemination or timed intercourse.
design_group_title: # 2 - Progesterone Vaginal Gel 8%
design_group_type: Active Comparator
Sponsor: Eastern Virginia Medical School
Collaborators: Actavis, Inc.
Drug name mappings:
name: 来曲唑
lang: CN
name: Letrozole
lang: EN
name: レトロゾール
lang: JP
name: 黄体酮
lang: CN
name: Progesterone
lang: EN
name: プロゲステロン
lang: JP